Topical hemostatic powder is a mineral powder that forms an adherent barrier and coagulates active bleeding in the gastrointestinal (GI) tract. Hemospray is the first hemostatic powder approved by the Food and Drug Administration (FDA) in the United States. Hemospray has been increasingly used to manage GI bleeding. However, data on the adverse events of hemostatic powders are lacking. Therefore, we aim to report and analyze adverse events associated with Hemospray using the FDA's "Manufacturer and User Facility Device Experience" database.

We analyzed the postmarketing surveillance data from the FDA's Manufacturer and User Facility Device Experience database for Hemospray, initially known as TC-325, from June 2018 through April 2022. Results of the search were classified into device-related technical issues, patient-related adverse events and health care staff-related adverse events.

Five hundred two medical device reporting claims were identified from June 2018 through April 2022. Seven duplicate claims were identified, and some claims included more than one event type. Therefore, there were 558 device-related problems, 28 patient-related adverse events, and 2 adverse events in health care staff members. The most common device-related problems were activation failure or failure to fire (n = 385, 70.0%) and obstruction of carbon dioxide flow (n = 121, 21.7). The most common patient-related adverse events included tissue injury or bleeding (n = 21) and perforation (n = 5).

Although Hemospray is a valuable tool in the armamentarium for endoscopists in managing GI bleeding, endoscopists must be mindful of deice-related problems and potential patient-related adverse events.

Obesity is associated with several chronic conditions including diabetes, cardiovascular disease, and metabolic dysfunction-associated steatotic liver disease and malignancy. Bariatric surgery, most commonly Roux-en-Y gastric bypass and sleeve gastrectomy, is an effective treatment modality for obesity and can improve associated comorbidities. Over the last 20 years, there has been an increase in the rate of bariatric surgeries associated with the growing obesity epidemic. Sleeve gastrectomy is the most widely performed bariatric surgery currently, and while it serves as a durable option for some patients, it is important to note that several complications, including sleeve leak, stenosis, chronic fistula, gastrointestinal hemorrhage, and gastroesophageal reflux disease, may occur. Endoscopic methods to manage post-sleeve gastrectomy complications are often considered due to the risks associated with a reoperation, and endoscopy plays a significant role in the diagnosis and management of post-sleeve gastrectomy complications. We perform a detailed review of the current endoscopic management of post-sleeve gastrectomy complications.

Over-the-scope clip (OTSC) has been used recently for primary haemostasis of peptic ulcers. This study aimed to compare the efficacy of OTSC to standard endoscopic therapy in primary treatment of patients with peptic ulcer bleeding that are of size ≥1.5 cm. The target population accounts for only 2.5% of all upper GI bleeders.

This was a multicentre international randomised controlled trial from July 2017 to October 2020. All patients with Forest IIa or above peptic ulcers of ≥1.5 cm were included. Primary outcome was 30-day clinical rebleeding. Secondary endpoints include 3-day all-cause mortality, transfusion requirement, hospital stay, technical and clinical success, and further interventions. 100 patients are needed to yield a power of 80% to detect a difference of -0.15 at the 0.05 significance level (alpha) using a two-sided Z-test (pooled).

100 patients were recruited. Success in achieving primary haemostasis was achieved in 46/50 (92%) and 48/50 (96%) in the OTSC and conventional arm, respectively. Among patients who had success in primary haemostasis, 2/46 (4.35%) patients in the OTSC arm and 9/48 (18.75%) patients in the conventional arm developed 30-day rebleeding (p=0.03). However, in an intention-to-treat analysis, there was no difference in rebleeding within 30 days (5/50 (10%) OTSC vs 9/50 (18%) standard, p=0.23) or all-cause mortality (2/50 (4%) OTSC vs 4/50 (8%) standard, p=0.68; OR=2.09, 95% CI 0.37 to 11.95). There was also no difference in transfusion requirement, hospital stay, intensive care unit admission and further interventions.

The routine use of OTSC as primary haemostasis in large bleeding peptic ulcers was not associated with a significant decrease in 30-day rebleeding.

NCT03160911.

Gastrointestinal bleeding occurs frequently in clinical practice. The presence of gastrointestinal bleeding usually is suspected by typical clinical history and results of clinical examination and laboratory findings. Endoscopic treatment of gastrointestinal bleeding is associated with high success rates over 90%. Different techniques for endoscopic hemostasis are available and for most indications, a combination of two modalities is recommended. Endoscopic management of recurrent or persistent bleeding is technically more challenging and associated with increased mortality (up to 10%, especially in patients with high age and comorbidities). In this situation, endoscopic hemostasis using an over-the-scope clip has shown to be superior to standard treatment for recurrent peptic ulcer bleeding in the upper gastrointestinal tract. Recent studies also have shown superiority for first-line over-the-scope clip treatment of non-variceal upper gastrointestinal bleeding in high-risk patients. In this review, management of gastrointestinal bleeding is summarized based on current guidelines and current literature.

Upper GI bleeding (UGIB) is a common condition associated with significant morbidity and mortality. Endoscopic hemostasis remains the mainstay of therapy and is mainly aimed at effective hemostasis and prevention of rebleeding. Lesions with high-risk stigmata can have rebleeding rates of as high as 26.3%. Rebleeding is associated with increased mortality and reduced success rates of endoscopic retreatment. The over-the-scope-clip (OTSC) is a device with widespread endoscopic indications including hemostasis for nonvariceal UGIB (NVUGIB). The current study presents a systematic review and meta-analysis comparing OTSCs versus standard therapy (STD) for NVUGIB.

Multiple databases were searched through April 2022 for studies comparing OTSCs and STD for NVUGIBs. Primary outcomes were clinical success rates, rebleeding rates, and procedure times, and secondary outcomes were mortality rates and length of hospitalization. Meta-analysis was performed to determine pooled odds ratios to compare outcomes between the OTSC and STD groups.

Ten studies, including 4 randomized controlled trials, with 914 patients were included in the final analysis. Of patients with NVUGIB, 431 were treated with OTSCs and 483 with STD. Patients treated with OTSCs had an overall lower risk of 7-day (risk ratio [RR], .41; 95% confidence interval [CI], .24-.68; I2 = 0%) and 30-day rebleeding (RR, .46; 95% CI, .31-.65; I2 = 0%). Clinical success rates were higher with OTSCs compared with STD (RR, 1.36; 95% CI, 1.06-1.75). Mean procedure time was shorter in the OTSC group by 6.62 minutes (95% CI, 2.58-10.67) versus the STD group (I2 = 84%). There was no statistically significant difference in terms of mortality between the OTSC and STD groups (RR, .55; 95% CI, .24-1.24; I2 = 0%). Length of hospitalization was comparable between both groups, with a pooled mean difference for OTSCs versus STD of .87 days (95% CI, -1.62 to 3.36 days; I2 = 71%).

Although our study was limited to high-risk NVUGIB, our analysis showed that hemostasis with OTSCs is associated with a lower 7-day and 30-day rebleeding rates, higher clinical success rates, and shorter procedure time with similar mortality rates and length of hospital stay as compared with STD.

Non-variceal upper gastrointestinal bleeding (NVUGIB) is a common type of upper gastrointestinal emergency with high risk of life-threatening conditions. Nowadays some standard guidelines for the treatments of NVUGIB have been established based on endoscopic therapies, including injection of glues or sclerosing agents, coiling, band ligation, and thermal therapies. Nevertheless, some patients are refractory to standard endoscopic treatments. We have noticed that endoscopic ultrasound (EUS)-guided treatments have been performed by some endoscopists in certain conditions. This review aims to evaluate the role of EUS-guided treatments in the management of NVUGIB. We performed a MEDLINE/PubMed search, and relevant studies were extracted and examined. According to the existing literature, the most common lesions were Dieulafoy's lesion, pancreatic pseudoaneurysms, and gastrointestinal stromal tumors. EUS-guided treatments mainly include injection, mechanical therapies, and combined therapies, and seem to be a promising technique in the management of NVUGIB, especially for refractory bleeding.

The purpose of this study was to evaluate the clinical outcomes, including patient prognosis and medication expense, of proton pump inhibitors administered by high-dose continuous infusion (HDC, 80 mg loading dose, then 8 mg/h for 72 hours) or non-high-dose intermittent infusion (NHDI, 40 mg qd or 40 mg q12 h, for 3 days) regimens in high-risk patients with bleeding peptic ulcers.In this retrospective cohort study, patients with peptic ulcers and endoscopic hemostasis between January, 2013 and December, 2015 were included. The primary endpoints were rebleeding and mortality rates within 7 days. The secondary endpoints were length of stay (LOS), transfusion units of packed red blood cells (PRBCs), and the number needed to treat.A total of 335 patients met the inclusion criteria during the 3-year follow-up period. The cumulative incidence of rebleeding within 7 days was 20.4% and 11.2% in the HDC and NHDI groups, respectively, with a significant difference (P = .021). The mortality rate was 12.1% and 7.3% in the HDC and NHDI groups, respectively, with no significant difference (P = .136). Univariate Cox proportional hazards model analysis showed that the risk of rebleeding within 7 days in the HDC group was higher than that in the NHDI group. The hazard ratio for HDC vs. NHDI was 1.93 (P = .021). There were significant differences in LOS (P = .034) and PRBC units (P = .005) for risk of rebleeding within 7 days, as well as in transfusion units of PRBCs for mortality rate analysis (p < 0.001), between the HDC and NHDI groups. The results showed that the NHDI regimen could reduce the risk of rebleeding within 7 days in 1 of 11 patients (number needed to treat = 11) and could reduce medication cost by US$ 400 to 800.The NHDI regimen showed a lower risk of rebleeding within 7 days, shorter LOS, and fewer PRBC units than that of the HDC regimen. Receiving NHDI has better cost-effective outcomes than that of HDC for patients with high-risk bleeding peptic ulcers.

Upper gastrointestinal bleeding (UGIB) is a common medical emergency with significant mortality. Despite developments in endoscopic and clinical management, only minor improvements in outcomes have been reported.

This was a retrospective cohort study of patients with non-malignant UGIB emergency admissions in England between 2003 and 2015, using Hospital Episode Statistics. Multilevel logistic regression analysis examined the associations with mortality.

242 796 patients with an UGIB admission were identified (58.8 % men; median age 70 [interquartile range (IQR) 53 - 81]). Between 2003 and 2015, falls occurred in both 30-day mortality (7.5 % to 7.0 %; P < 0.001) and age-standardized mortality (odds ratio (OR) 0.74, 95 % confidence interval [CI] 0.69 - 0.80; P < 0.001), including from variceal bleeding (OR 0.63, 95 %CI 0.45 - 0.87; P < 0.005). Increasing co-morbidity (Charlson score > 5, OR 2.94, 95 %CI 2.85 - 3.04; P < 0.001), older age (> 83 years, OR 6.50, 95 %CI 6.09 - 6.94; P < 0.001), variceal bleeding (OR 2.03, 95 %CI 1.89 - 2.18; P < 0.001), and a weekend admission (Sunday, OR 1.18, 95 %CI 1.12 - 1.23; P < 0.001) were associated with 30-day mortality. Of deaths at 30 days, 8.9 % were from ischemic heart disease (IHD) and the cardiovascular age-standardized mortality rate following UGIB was high (IHD deaths within 1 year, 1188.4 [95 %CI 1036.8 - 1353.8] per 100 000 men in 2003).

Between 2003 and 2015, 30-day mortality among emergency admissions with non-malignant UGIB fell by 0.5 % to 7.0 %. Mortality was higher among UGIB admissions at the weekend, with important implications for service provision. Patients with UGIB had a much greater risk of subsequently dying from cardiovascular disease and addressing this risk is a key management step in UGIB.

the lack of standardized pathways for patients with gastrointestinal bleeding may have led to differences in their management and inequity to medical care access. The "Hub & Spoke" model was adopted to fill this gap in many disciplines, but, to our knowledge, no data exist on its efficacy on mortality in GI bleeding. We aimed to evaluate if the "Hub & Spoke" organizational model has an impact on mortality risk from UGIB.

from January 2014 to December 2015, 3324 consecutive patients admitted for UGIB in 50 Italian hospitals were enrolled (1977 patients in hospitals within the "Hub & Spoke" network for digestive hemorrhagic emergency and 1347 in hospitals outside the "Hub & Spoke" network). Clinical, endoscopic and organizational data were recorded.

we observed no differences in mortality between patients admitted to hospitals included or not included in the "Hub & Spoke" network (5.2% vs 6.1%, p = 0.3). On multivariate analysis, admission in gastroenterology wards (OR 0.61, p = 0.001) or an academic hospital (OR 0.65, p < 0.056) were independent protective factors while being in "Hub & Spoke" organization system did not affect mortality (OR 1.09, p = 0.57).

the "Hub & Spoke" model per sé does not impact on mortality while being treated in academic hospital or gastroenterology wards improved survival.

The gastrointestinal tract is a long tubular structure wherein any point in the mucosa along its entire length could be the source of a hemorrhage. Upper (esophagel and gastroduodenal) and lower (jejunum, ileum, and colon) gastrointestinal bleeding are common. Gastroduodenal and colonic bleeding are more frequent than bleeding from the small bowel, but nowadays the entire gastrointestinal tract can be explored endoscopically and bleeding lesions can be locally treated successfully to stop or prevent further bleeding. The extensive use of antiplatelet and anticoagulants drugs in cardiovascular patients is, at least in part, the cause of the increasing number of patients suffering from gastrointestinal bleeding. Patients with these conditions are usually older and more fragile because of their comorbidities. The correct management of antithrombotic drugs in cases of gastrointestinal bleeding is essential for a successful outcome for patients. The influence of the microbiome in the pathogenesis of small bowel bleeding is an example of the new data that are emerging as potential therapeutic target for bleeding prevention. This text summarizes the latest research and advances in all forms of acute gastrointestinal bleeding (i.e., upper, small bowel and lower). Diagnosis is approached, and medical, endoscopic or antithrombotic management are discussed in the text in an accessible and comprehensible way.

Proton pump inhibitors (PPIs) decrease the rate of rebleeding following endoscopic hemostatic therapy in patients with bleeding peptic ulcers. This study compares the efficacy of oral omeprazole vs intravenous omeprazole in decrease of rebleeding of peptic ulcer patients.

The present study was authorized by the local research ethics committee of Jiangjin District Central Hospital (2020120987) and informed consent was obtained from all patients. All adult patients who were admitted to medical emergency rooms of Jiangjin District Central Hospital due to upper gastrointestinal bleeding (as evidenced by hematemesis, melena or hematochezia) were considered for inclusion in the study. Endoscopy was performed within 24 hours after admission. Patients older than 18 years with successful endoscopic therapy of high risk ulcers [defined as active bleeding (Forrest IA, IB), non-bleeding visible vessel (NBVV, Forrest IIA) or adherent clots (Forrest IIB)] were enrolled. Patients with low risk ulcers (clean base, ulcers with a simple washable clot), suspicious malignant ulcer, bleeding tendency, uremia, liver cirrhosis, Mallory Weiss tear or already on PPI as an outpatient were excluded from study. All were managed endoscopically by injecting 5-30 ml of epinephrine (diluted 1:10000) around the ulcer crater. Cavitations or flattening of bleeding vessel and disappearance of NBVV was considered as established homeostasis. A biopsy was taken from antrum for evaluating Helicobacter pylori infection. Patient with unsuccessful endoscopic therapy were not enrolled and were referred to general surgeon. Information on demography, history of previous upper gastrointestinal bleeding, NSAID or ASA ingestion, ulcer location, bleeding stigmata and blood transfusion volume at entry were recorded in all patients. In the oral omeprazole group, the patients received 40 mg omeprazole orally twice daily for 72 hours. In intravenous omeprazole group, they received omeprazole 80 mg bolus and then 8 mg/hour infusion for 48-72 hours. Then, all patients received omeprazole 20 mg orally for 30 days. On the day of discharge Helicobacter pylori infected patients received standard regimens.

Figure 1 showed the primary and secondary end points.

Intravenous administration of PPIs has limitations. They are expensive, require a dedicated intravenous line, need nursing supervision and hospital admission. So, it would be reasonable to prescribe oral PPIs to patients with high risk bleeding ulcers provided that it is as effective as its intravenous counterpart. Oral PPIs have a high bioavailability. Its effect initiates one hour after ingestion and the maximal plasma concentration is achieved after 2-3 hours. However, there are few studies comparing oral and intravenous PPI in decreasing risk of rebleeding in peptic ulcer patients. More high quality randomized controlled trials are still necessary.

researchregistry 6588.

Gastrointestinal (GI) bleeding is a common medical emergency associated with significant mortality. Transcatheter arterial embolization first was introduced by Rosch et al as an alternative to surgery for upper GI bleeding. The clinical success in patients with GI bleeding treated with transcatheter arterial embolization previously has been reported. However, there are no cost-effectiveness analyses reported to date. Here we report cost-effectiveness analysis of N-butyl 2-cyanoacrylate glue (NBCA) and ethylene-vinyl alcohol copolymer (Onyx) versus coil (gold standard) for treatment of GI bleeding from a healthcare payer perspective.

Fixed-effects modeling with a generalized linear mixed method was used in NBCA and coil intervention arms to determine the pooled probabilities of clinical success and mortality with complications with their confidence intervals, while the Clopper-Pearson model was used for Onyx to determine the same parameters. Models were provided by the "Meta-Analysis with R" software package. A decision tree was built for cost-effectiveness analysis, and Microsoft Excel was used for probabilistic sensitivity analysis. The cost-effective option was determined based on the incremental cost-effectiveness ratio and scatter plots of incremental cost versus incremental quality-adjusted life-years.

Comparing scatter plots and incremental cost-effectiveness ratio results, -$1024 and -$1349 per quality-adjusted life-year for Onyx and N-butyl 2-cyanoacrylate glue, respectively, Onyx was the least expensive and most effective intervention.

Onyx was the dominant strategy regardless of threshold values. Our analyses provide a framework for researchers to predict the target clinical effectiveness for early-stage TAE interventions and guide resource allocation decisions.

1: ESGE recommends in patients with acute upper gastrointestinal hemorrhage (UGIH) the use of the Glasgow-Blatchford Score (GBS) for pre-endoscopy risk stratification. Patients with GBS ≤ 1 are at very low risk of rebleeding, mortality within 30 days, or needing hospital-based intervention and can be safely managed as outpatients with outpatient endoscopy.Strong recommendation, moderate quality evidence. 2: ESGE recommends that in patients with acute UGIH who are taking low-dose aspirin as monotherapy for secondary cardiovascular prophylaxis, aspirin should not be interrupted. If for any reason it is interrupted, aspirin should be re-started as soon as possible, preferably within 3-5 days.Strong recommendation, moderate quality evidence. 3: ESGE recommends that following hemodynamic resuscitation, early (≤ 24 hours) upper gastrointestinal (GI) endoscopy should be performed. Strong recommendation, high quality evidence. 4: ESGE does not recommend urgent (≤ 12 hours) upper GI endoscopy since as compared to early endoscopy, patient outcomes are not improved. Strong recommendation, high quality evidence. 5: ESGE recommends for patients with actively bleeding ulcers (FIa, FIb), combination therapy using epinephrine injection plus a second hemostasis modality (contact thermal or mechanical therapy). Strong recommendation, high quality evidence. 6: ESGE recommends for patients with an ulcer with a nonbleeding visible vessel (FIIa), contact or noncontact thermal therapy, mechanical therapy, or injection of a sclerosing agent, each as monotherapy or in combination with epinephrine injection. Strong recommendation, high quality evidence. 7 : ESGE suggests that in patients with persistent bleeding refractory to standard hemostasis modalities, the use of a topical hemostatic spray/powder or cap-mounted clip should be considered. Weak recommendation, low quality evidence. 8: ESGE recommends that for patients with clinical evidence of recurrent peptic ulcer hemorrhage, use of a cap-mounted clip should be considered. In the case of failure of this second attempt at endoscopic hemostasis, transcatheter angiographic embolization (TAE) should be considered. Surgery is indicated when TAE is not locally available or after failed TAE. Strong recommendation, moderate quality evidence. 9: ESGE recommends high dose proton pump inhibitor (PPI) therapy for patients who receive endoscopic hemostasis and for patients with FIIb ulcer stigmata (adherent clot) not treated endoscopically. (A): PPI therapy should be administered as an intravenous bolus followed by continuous infusion (e. g., 80 mg then 8 mg/hour) for 72 hours post endoscopy. (B): High dose PPI therapies given as intravenous bolus dosing (twice-daily) or in oral formulation (twice-daily) can be considered as alternative regimens.Strong recommendation, high quality evidence. 10: ESGE recommends that in patients who require ongoing anticoagulation therapy following acute NVUGIH (e. g., peptic ulcer hemorrhage), anticoagulation should be resumed as soon as the bleeding has been controlled, preferably within or soon after 7 days of the bleeding event, based on thromboembolic risk. The rapid onset of action of direct oral anticoagulants (DOACS), as compared to vitamin K antagonists (VKAs), must be considered in this context.Strong recommendation, low quality evidence.

Acute peptic ulcer bleeding is still a major reason for hospital admission. Especially the management of bleeding duodenal ulcers needs a structured therapeutic approach due to the higher morbidity and mortality compared to gastric ulcers. Patient with these bleeding ulcers are often in a high-risk situation, which requires multidisciplinary treatment.

This review provides a structured approach to modern management of bleeding duodenal ulcers and elucidates therapeutic practice in high-risk situations. Initial management including pharmacologic therapy, risk stratification, endoscopy, surgery, and transcatheter arterial embolization are reviewed and their role in the management of bleeding duodenal ulcers is critically discussed. Additionally, a future perspective regarding prophylactic therapeutic approaches is outlined.

Beside pharmacotherapeutic and endoscopic advances, bleeding management of high-risk duodenal ulcers is still a challenge. When bleeding persists or rebleeding occurs and the gold standard endoscopy fails, surgical and radiological procedures are indicated to manage ulcer bleeding. Surgical procedures are performed to control hemorrhage, but they are still associated with a higher morbidity and a longer hospital stay. In the meantime, transcatheter arterial embolization is recommended as an alternative to surgery and more often replaces surgery in the management of failed endoscopic hemostasis. Future studies are needed to improve risk stratification and therefore enable a better selection of high-risk ulcers and optimal treatment. Additionally, the promising approach of prophylactic embolization in high-risk duodenal ulcers has to be further investigated to reduce rebleeding and improve outcomes in these patients.

The incidence of peptic ulcer disease (PUD) has been decreasing over time with Helicobacter pylori eradication and use of acid-suppressing therapies. However, PUD remains a common cause of hospitalization in the United States. We aimed to evaluate contemporary national trends in the incidence, treatment patterns, and outcomes for PUD-related hospitalizations and compare care delivery by hospital rurality.

Data from the National Inpatient Sample were used to estimate weighted annual rates of PUD-related hospitalizations. Temporal trends were evaluated by joinpoint regression and expressed as annual percent change with 95% confidence intervals (CIs). We determined the proportion of hospitalizations requiring endoscopic and surgical interventions, stratified by clinical presentation and rurality. Multivariable logistic regression was used to assess independent predictors of in-hospital mortality and postoperative morbidity.

There was a 25.8% reduction (P < 0.001) in PUD-related hospitalizations from 2005 to 2014, although the rate of decline decreased from -7.2% per year (95% CI: 13.2% to -0.7%) before 2008 to -2.1% per year (95% CI: 3.0% to -1.1%) after 2008. In-hospital mortality was 2.4% (95% CI: 2.4%-2.5%). Upper endoscopy (84.3% vs 78.4%, P < 0.001) and endoscopic hemostasis (26.1% vs 16.8%, P < 0.001) were more likely to be performed in urban hospitals, whereas surgery was performed less frequently (9.7% vs 10.5%, P < 0.001). In multivariable logistic regression, patients managed in urban hospitals were at higher risk for postoperative morbidity (odds ratio 1.16 [95% CI: 1.04-1.29]), but not death (odds ratio 1.11 [95% CI: 1.00-1.23]).

The rate of decline in hospitalization rates for PUD has stabilized over time, although there remains significant heterogeneity in treatment patterns by hospital rurality.

Upper gastrointestinal bleeding (UGIB) is a leading cause of morbidity and is associated with a 2 % - 17 % mortality rate in the UK and USA. Bleeding peptic ulcers account for 50 % of UGIB cases. Endoscopic intervention in a timely manner can improve outcomes. Hemostatic spray is an endoscopic hemostatic powder for GI bleeding. This multicenter registry was created to collect data prospectively on the immediate endoscopic hemostasis of GI bleeding in patients with peptic ulcer disease when hemostatic spray is applied as endoscopic monotherapy, dual therapy, or rescue therapy.

Data were collected prospectively (January 2016 - March 2019) from 14 centers in the UK, France, Germany, and the USA. The application of hemostatic spray was decided upon at the endoscopist's discretion.

202 patients with UGIB secondary to peptic ulcers were recruited. Immediate hemostasis was achieved in 178/202 patients (88 %), 26/154 (17 %) experienced rebleeding, 21/175 (12 %) died within 7 days, and 38/175 (22 %) died within 30 days (all-cause mortality). Combination therapy of hemostatic spray with other endoscopic modalities had an associated lower 30-day mortality (16 %, P < 0.05) compared with monotherapy or rescue therapy. There were high immediate hemostasis rates across all peptic ulcer disease Forrest classifications.

This is the largest case series of outcomes of peptic ulcer bleeding treated with hemostatic spray, with high immediate hemostasis rates for bleeding peptic ulcers.

The clinical outcome of upper gastrointestinal bleeding has improved due to advances in endoscopic therapy and standardized peri-endoscopy care. Apart from validating clinical scores, artificial intelligence-assisted machine learning models may play an important role in risk stratification. While standard endoscopic treatments remain irreplaceable, novel endoscopic modalities have changed the landscape of management. Over-the-scope clips have high success rates as rescue or even first-line treatments in difficult-to-treat cases. Hemostatic powder is safe and easy to use, which can be useful as temporary control with its high immediate hemostatic ability. After endoscopic hemostasis, Doppler endoscopic probe can offer an objective measure to guide the treatment endpoint. In refractory bleeding, angiographic embolization should be considered before salvage surgery. In variceal hemorrhage, banding ligation and glue injection are first-line treatment options. Endoscopic ultrasound-guided therapy is gaining popularity due to its capability of precise localization for treatment targets. A self-expandable metal stent may be considered as an alternative option to balloon tamponade in refractory bleeding. Transjugular intrahepatic portosystemic shunting should be reserved as salvage therapy. In this article, we aim to provide an evidence-based comprehensive review of the major advancements in endoscopic hemostatic techniques and clinical outcomes.

The purpose of this American Gastroenterological Association (AGA) Institute Clinical Practice Update is to review the available evidence and best practice advice statements regarding the use of endoscopic therapies in treating patients with non-variceal upper gastrointestinal bleeding.

This expert review was commissioned and approved by the AGA Institute Clinical Practice Updates Committee and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership, and underwent internal peer review by the Clinical Practice Updates Committee and external peer review through standard procedures of Gastroenterology. This review is framed around the 10 best practice advice points agreed upon by the authors, which reflect landmark and recent published articles in this field. This expert review also reflects the experiences of the authors who are gastroenterologists with extensive experience in managing and teaching others to treat patients with non-variceal upper gastrointestinal bleeding (NVUGIB). BEST PRACTICE ADVICE 1: Endoscopic therapy should achieve hemostasis in the majority of patients with NVUGIB. BEST PRACTICE ADVICE 2: Initial management of the patient with NVUGIB should focus on resuscitation, triage, and preparation for upper endoscopy. After stabilization, patients with NVUGIB should undergo endoscopy with endoscopic treatment of sites with active bleeding or high-risk stigmata for rebleeding. BEST PRACTICE ADVICE 3: Endoscopists should be familiar with the indications, efficacy, and limitations of currently available tools and techniques for endoscopic hemostasis, and be comfortable applying conventional thermal therapy and placing hemoclips. BEST PRACTICE ADVICE 4: Monopolar hemostatic forceps with low-voltage coagulation can be an effective alternative to other mechanical and thermal treatments for NVUGIB, particularly for ulcers in difficult locations or those with a rigid and fibrotic base. BEST PRACTICE ADVICE 5: Hemostasis using an over-the-scope clip should be considered in select patients with NVUGIB, in whom conventional electrosurgical coagulation and hemostatic clips are unsuccessful or predicted to be ineffective. BEST PRACTICE ADVICE 6: Hemostatic powders are a noncontact endoscopic option that may be considered in cases of massive bleeding with poor visualization, for salvage therapy, and for diffuse bleeding from malignancy. BEST PRACTICE ADVICE 7: Hemostatic powder should be preferentially used as a rescue therapy and not for primary hemostasis, except in cases of malignant bleeding or massive bleeding with inability to perform thermal therapy or hemoclip placement. BEST PRACTICE ADVICE 8: Endoscopists should understand the risk of bleeding from therapeutic endoscopic interventions (eg, endoluminal resection and endoscopic sphincterotomy) and be familiar with the endoscopic tools and techniques to treat intraprocedural bleeding and minimize the risk of delayed bleeding. BEST PRACTICE ADVICE 9: In patients with endoscopically refractory NVUGIB, the etiology of bleeding (peptic ulcer disease, unknown source, post surgical); patient factors (hemodynamic instability, coagulopathy, multi-organ failure, surgical history); risk of rebleeding; and potential adverse events should be taken into consideration when deciding on a case-by-case basis between transcatheter arterial embolization and surgery. BEST PRACTICE ADVICE 10: Prophylactic transcatheter arterial embolization of high-risk ulcers after successful endoscopic therapy is not encouraged.

Within the project "Quality indicators in digestive endoscopy", pioneered by the Spanish Society for Digestive Diseases (SEPD), the objective of this research is to suggest the structure, process, and results procedures and indicators necessary to implement and assess quality in the gastroscopy setting. First, a chart was designed with the steps to be followed during a gastroscopy procedure. Secondly, a team of experts in care quality and/or endoscopy performed a qualitative review of the literature searching for quality indicators for endoscopic procedures, including gastroscopies. Finally, using a paired analysis approach, a selection of the literature obtained was undertaken. For gastroscopy, a total of nine process indicators were identified (one preprocedure, eight intraprocedure). Evidence quality was assessed with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) classification scale.

Non-variceal gastrointestinal bleeding (GIB) is a significant cause of mortality and morbidity worldwide which is encountered in the ambulatory and hospital settings. Hemorrhage form the gastrointestinal (GI) tract is categorized as upper GIB, small bowel bleeding (also formerly referred to as obscure GIB) or lower GIB. Although the etiologies of GIB are variable, a strong, consistent risk factor is use of non-steroidal anti-inflammatory drugs. Advances in the endoscopic diagnosis and treatment of GIB have led to improved outcomes. We present an updated review of the current practices regarding the diagnosis and management of non-variceal GIB, and possible future directions.

Peptic ulcer disease is common with a lifetime prevalence in the general population of 5-10% and an incidence of 0.1-0.3% per year. Despite a sharp reduction in incidence and rates of hospital admission and mortality over the past 30 years, complications are still encountered in 10-20% of these patients. Peptic ulcer disease remains a significant healthcare problem, which can consume considerable financial resources. Management may involve various subspecialties including surgeons, gastroenterologists, and radiologists. Successful management of patients with complicated peptic ulcer (CPU) involves prompt recognition, resuscitation when required, appropriate antibiotic therapy, and timely surgical/radiological treatment.

The present guidelines have been developed according to the GRADE methodology. To create these guidelines, a panel of experts was designed and charged by the board of the WSES to perform a systematic review of the available literature and to provide evidence-based statements with immediate practical application. All the statements were presented and discussed during the 5th WSES Congress, and for each statement, a consensus among the WSES panel of experts was reached.

The population considered in these guidelines is adult patients with suspected complicated peptic ulcer disease. These guidelines present evidence-based international consensus statements on the management of complicated peptic ulcer from a collaboration of a panel of experts and are intended to improve the knowledge and the awareness of physicians around the world on this specific topic. We divided our work into the two main topics, bleeding and perforated peptic ulcer, and structured it into six main topics that cover the entire management process of patients with complicated peptic ulcer, from diagnosis at ED arrival to post-discharge antimicrobial therapy, to provide an up-to-date, easy-to-use tool that can help physicians and surgeons during the decision-making process.

Acute gastrointestinal bleeding carries poor outcomes unless prompt endoscopic hemostasis is achieved. Mortality in these patients remains significant. Hemospray is a novel intervention that creates a mechanical barrier over bleeding sites. We report the largest dataset of patient outcomes after treatment with Hemospray from an international multicenter registry.

Prospective data (Jan 2016-May 2018) from 12 centers across Europe were collected. Immediate hemostasis was defined as endoscopic cessation of bleeding within 5 min after application of Hemospray. Rebleeding was defined as subsequent drop in hemoglobin, hematemesis, persistent melena with hemodynamic compromise post-therapy.

Three hundred and fourteen cases were recruited worldwide (231 males, 83 females). Median pretreatment Blatchford score was 11 (IQR: 8-14) and median complete Rockall score (RS) was 7 (IQR: 6-8) for all patients. Peptic ulcer disease (PUD) was the most common pathology (167/314 = 53%) and Forrest Ib the most common bleed type in PUD (100/167 = 60%). 281 patients (89.5%) achieved immediate hemostasis after successful endoscopic therapy with Hemospray. Rebleeding occurred in 29 (10.3%) of the 281 patients who achieved immediate hemostasis. Seven-day and 30-day all-cause mortality were 11.5% (36/314) and 20.1% (63/314), respectively (lower than the predicted rates as per the RS). Similar hemostasis rates were noted in the Hemospray monotherapy (92.4%), combination therapy (88.7%) and rescue therapy (85.5%) groups.

These data show high rates of immediate hemostasis overall and in all subgroups. Rebleeding and mortality rates were in keeping/lower than predicted rates.

Conventional endoscopic treatments can't control bleeding in as many as 20% of patients with non-variceal gastrointestinal (GI) bleeding. Recent studies have shown that over-the-scope-clip (OTSC) system allowed for effective hemostasis for refractory GI bleeding lesions. So we aimed to conduct a systematic review to evaluate the effectiveness and safety of the OTSC system for management of acute non-variceal upper GI bleeding.

A comprehensive literature search was conducted on PubMed, EMBASE, and Cochrane Library covering the period from January 2007 to May 2019. The literature was selected independently by two reviewers according to the inclusion and exclusion criteria. The statistical analysis was carried out using Comprehensive Meta-Analysis software version 3.0.

A total of 16 studies including 769 patients with 778 GI bleeding lesions were identified. Pooled technical success was achieved in 761 lesions [95.7%; 95% confidence interval (CI), 93.5-97.2%], and the pooled clinical success was achieved in 666 lesions (84.2, 95% CI, 77.4-89.2%). The incidence of re-bleeding was reported in 81 patients and the post-procedure mortality was 10.9% (n = 84). Only 2 (0.3%) patients occurred complications after OTSC system procedure.

Our study demonstrated that the OTSC system was a technically feasible modality and highly efficacious in achieving hemostasis in acute non-variceal upper gastrointestinal bleeding.

Bleeding from unresectable gastric cancer (URGC) is not a rare complication. Two major ways in which the management of this issue differs from the management of benign lesions are the high rate of rebleeding after successful hemostasis and that not only endoscopic therapy (ET) and transcatheter arterial embolization (TAE) but palliative radiotherapy (PRT) can be applied in the clinical setting. However, there are no specific guidelines concerning the management of URGC with bleeding. We herein discuss strategies for managing bleeding from URGC. A high rate of initial hemostasis for active bleeding is expected when using various ET modalities properly. If ET fails in patients with hemostatic instability, emergent TAE is considered in order to avoid a life-threating condition due to massive bleeding. Early PRT, especially, regimens with a high biologically effective dose (BED) of ≥39 Gy should be considered not only for patients with hemostatic failure but also for those with successful hemostasis and inactive hemorrhage, as longer duration of response with few complications can be expected. Further prospective, comparative studies considering not only the hemostatic efficacy of these modalities but the patients' quality of life are needed in order to establish treatment strategies for bleeding from URGC.

Endoscopic intervention is often the first line of therapy for GI nonvariceal bleeding. Although some of the devices and techniques used for this purpose have been well studied, others are relatively new, with few available outcomes data.

In this document, we review devices and techniques for endoscopic treatment of nonvariceal GI bleeding, the evidence regarding their efficacy and safety, and financial considerations for their use.

Devices used for endoscopic hemostasis in the GI tract can be classified into injection devices (needles), thermal devices (multipolar/bipolar probes, hemostatic forceps, heater probe, argon plasma coagulation, radiofrequency ablation, and cryotherapy), mechanical devices (clips, suturing devices, banding devices, stents), and topical devices (hemostatic sprays).

Endoscopic evaluation and treatment remains a cornerstone in the management of nonvariceal upper- and lower-GI bleeding. A variety of devices is available for hemostasis of bleeding lesions in the GI tract. Other than injection therapy, which should not be used as monotherapy, there are few compelling data that strongly favor any one device over another. For endoscopists, the choice of a hemostatic device should depend on the type and location of the bleeding lesion, the availability of equipment and expertise, and the cost of the device.

Endoscopic therapy is the mainstay of treatment for nonvariceal upper gastrointestinal bleeding (NVUGIB). Injection plus mechanical or thermal therapy continues to be the most widely used option. New endoscopic devices such as the use of an inert powder or a new class of over-the-scope clip system have demonstrated encouraging results as a rescue therapy for difficult hemostasis. Emerging data suggest that Doppler ultrasound-guided endoscopic therapy may improve the outcome of peptic ulcer bleeding. This review sumarizes the recent advances in the management of NVUGIB. With increasing use of anti-platelet agents and anti-coagulants, the management of NVUGIB in patients on anti-thrombotic therapy is also discussed.

We used 3-dimensional (3D) printing technology to create a new hemostasis simulator for the stomach and investigated its efficacy and realism in endoscopic hemostasis training.

A new stomach hemostasis simulator, with two hemostasis modules for hemoclipping and injection, was constructed using a 3D printer. Twenty-one endoscopists, including 11 first-year fellows (beginner group) and 10 faculty members (expert group), tested the performance of the simulator. We recorded and reviewed five training sessions and evaluated the simulator with questionnaires using a 7-point Likert scale.

The mean evaluation score of the expert group was 6.3±0.5 for the hemoclipping module and 6.0±0.6 for the injection module. The expert group strongly agreed that endoscopic handling in the simulator was realistic and reasonable for hemostasis training. The mean procedure time for hemoclipping was 72.7±7.1 seconds for the beginner group and 19.7±1.2 seconds for the expert group. The mean procedure time for injection was 92.1±9.8 seconds for the beginner group and 36.3±2 seconds for the expert group. The procedure time of beginner group became shorter with repetition and was significantly lower by the fifth trial.

A new 3D-printed hemostasis simulator is capable of hemostasis training and can very effectively train beginners before they perform the procedure in patients with gastrointestinal bleeding.

Acute upper gastrointestinal bleeding (AUGIB) is one of the most common medical emergencies in the UK. Despite advancement in technology the management of AUGIB remains a challenge. The clinical community recognise the need for improvement in the treatment of these patients. AUGIB has a significant impact on resources. Endoscopic therapy is the gold standard treatment. The mortality in AUGIB is rarely related to the presenting bleed but significantly associated with concurrent comorbidities. The cost of blood transfusion in the management of patients with AUGIB is significant and misuse of blood products has been documented nationally. Risk stratification tools such as Glasgow-Blatchford Score, Rockall Score and the AIMS65 score have allowed clinicians to triage patients appropriately in order to deliver endoscopic therapy within a suitable time frame. Endoscopic therapeutic modalities such as epinephrine injection, heat thermocoagulation and mechanical clips have had a positive impact on patient's management. However, in order to continue to improve patient's outcomes, further developments are needed.

BACKGROUND Proton pump inhibitors (PPIs) are now widely prescribed for the management of patients with acute upper gastrointestinal bleeding; although its optimal dose and route of administration has remained a controversial issue. The aim of this study was to assess the clinical effectiveness of high dose oral versus intravenous (IV) PPI after successful endoscopic therapy in patients with bleeding peptic ulcer disease. METHODS 178 patients with active upper gastrointestinal bleeding due to a peptic ulcer with stigmata of high risk for re-bleeding entered the study. After successful endoscopic hemostasis, they were randomized to receive either high dose oral pantoprazole (80 mg stat and 80 mg twice daily for 3 days) or high dose intravenous pantoprazole (80 mg IV infusion within 30 minutes and 8 mg per hour for 3 days). After the 3rd day, the patients in both groups received oral pantoprazole 40 mg twice daily for one month. The end points were comparing the rate of re-bleeding or mortality, and the need for blood transfusion or surgery during the first month between the two groups. RESULTS There were not significant statistical differences between the two groups in the volume of blood transfusion, mean duration of hospital stay, need to surgery, or mortality rates. However, the rates of re-bleeding were 2.3% (2:88) in the IV group and 3.3% (3:90) in the oral group (p = 0.6). CONCLUSION According to our findings, it seems that high dose oral PPI can be a good alternative to high dose IV PPI in patients with bleeding peptic ulcer who are at high risk of re-bleeding. Due to the lower cost and the availability of oral PPIs, their use can be economically much more affordable.

PURPOSE OF REVIEW: Upper non-variceal gastrointestinal bleeding (UNVGIB) remains an important clinical challenge for endoscopists, requiring skill and expertise for correct management. In this paper, we suggest the best strategy for an effective treatment of this complex category of patients.

Early endoscopic examination, the increasingly widespread use of endoscopic hemostasis methods, and the most powerful antisecretory agents that induce clot stabilization have radically modified the clinical scenario for treating this pathology. While hospitalization for digestive hemorrhage is decreasing, the incidence of bleeding seems to be increasing, especially in the elderly for whom a greater use of gastrolesive drugs and the presence of comorbidities are more common. A multidisciplinary approach for initial patient evaluation and hemodynamic resuscitation prior to endoscopic treatment is crucial for correct management, prevention of rebleeding, and reduction of morbidity and mortality rates and hospital stays. Appropriate operator technical expertise, together with the availability of a wide range of endoscopes and devices, is mandatory. Newer endoscopic techniques may improve patient outcomes for difficult-to-treat lesions. Today, endoscopic hemostasis can be achieved in over 95% of patients.

Peptic ulcer bleeding is common and associated with significant morbidity and mortality. We discuss the endoscopic assessment of peptic ulcers and the rationale for treatment. We also review the evidence for the available endoscopic therapies, both individually and in combination, to draw conclusions on the optimum endoscopic management of peptic ulcer bleeding.

This article examines use of the Doppler endoscopic probe (DEP) for risk stratification and as a guide to definitive hemostasis of nonvariceal upper gastrointestinal (NVUGI) bleeding and colonic diverticular hemorrhage. Studies report that lesions with high-risk stigmata of recent hemorrhage (SRH) have a higher rate of a positive DEP signal compared with those without such SRH. Lesions with a persistently positive DEP signal after endoscopic hemostasis have a higher 30-day rebleeding rate. Studies document arterial blood flow underneath stigmata of recent hemorrhage as a risk factor for rebleeding of focal nonvariceal gastrointestinal lesions. With DEP probe as a guide, rates of definitive endoscopic hemostasis and clinical outcomes are improved compared with standard visually guided treatment.

Non-variceal upper gastrointestinal bleeding (NVUGIB) is bleeding that develops in the oesophagus, stomach or proximal duodenum. Peptic ulcers, caused by Helicobacter pylori infection or use of NSAIDs and low-dose aspirin (LDA), are the most common cause. Although the incidence and mortality associated with NVUGIB have been decreasing owing to considerable advances in the prevention and management of NVUGIB over the past 20 years, it remains a common clinical problem with an annual incidence of ∼67 per 100,000 individuals in the United States in 2012. NVUGIB is a medical emergency, and mortality is in the range ∼1-5%. After resuscitation and initial assessment, early (within 24 hours) diagnostic and therapeutic endoscopy together with intragastric pH control with proton pump inhibitors (PPIs) form the basis of treatment. With a growing ageing population treated with antiplatelet and/or anticoagulant medications, the clinical management of NVUGIB is complex as the risk between gastrointestinal bleeding events and adverse cardiovascular events needs to be balanced. The best clinical approach includes identification of risk factors and prevention of bleeding; available strategies include continuous treatment with PPIs or H. pylori eradication in those at increased risk of developing NVUGIB. Treatment with PPIs and/or use of cyclooxygenase-2-selective NSAIDs should be implemented in those patients at risk of NVUGIB who need NSAIDs and/or LDA.

Non-variceal upper gastrointestinal bleeding continues to be an important cause of morbidity and mortality. The most common causes include peptic ulcer disease, Mallory-Weiss syndrome, erosive gastritis, duodenitis, esophagitis, malignancy, angiodysplasias and Dieulafoy's lesion. Initial assessment and early aggressive resuscitation significantly improves outcomes. Upper gastrointestinal endoscopy continues to be the gold standard for diagnosis and treatment. We present a comprehensive review of literature for the evaluation and management of non-variceal upper gastrointestinal bleeding.

The efficacy of proton pump inhibitors (PPIs) has been demonstrated for bleeding peptic ulcers but the route of administration remains controversial. Several studies have demonstrated that high-dose oral PPIs are as effective as intravenous PPIs in reducing recurrent bleeding. However, current guidelines recommend intravenous PPIs after endoscopic treatment. Previous data based on numbers that were too small to enable a firm conclusion to be reached suggested that oral and intravenous PPIs had equivalent efficacy. We undertook a meta-analysis to compare oral and intravenous PPIs in patients with bleeding peptic ulcers after endoscopic management.

A literature search was undertaken using MEDLINE, EMBASE and the Cochrane Library, between 1990 and February 2016, to identify all randomized controlled trials (RCTs) that assessed the efficacy of PPIs administered by different routes. Nine RCTs, involving 1036 patients, were analysed. Outcomes were: recurrent bleeding, blood transfusion requirement, duration of hospital stay, a need for repeat endoscopy, surgery and 30-day mortality.

There were no differences in the rebleeding rates [odds ratio (OR) 0.93, 95% confidence interval (CI) 0.60, 1.46; P = 0.77], need for surgery (OR 0.77, 95% CI 0.25, 2.40; P = 0.65), need for repeat endoscopy (OR 0.69, 95% CI 0.39, 1.21; P = 0.19), need for blood transfusion [(MD) -0.03, 95% CI -0.26, 0.19; P = 0.76], duration of hospital stay (MD -0.61, 95% CI -1.45, 0.23; P = 0.16) or 30-day mortality (OR 0.89, 95% CI 0.27, 2.43; P = 0.84) according to the route of administration.

Oral PPIs represent better value for money, with clinical efficacy equivalent to intravenous PPIs.

Preliminary studies on a new topical hemostatic agent, TC-325, have shown its safety and effectiveness in treating active upper gastrointestinal (GI) bleeding. However, to date there have been no randomized trials comparing TC-325 with the conventional combined technique (CCT). Our pilot study aimed to compare the efficacy and safety of TC-325 with those of CCT in treating peptic ulcers with active bleeding or high-risk stigmata.

This was a comparative randomized study of patients with upper GI bleeding who had Forrest class I, IIA or IIB ulcers.

Altogether 20 patients with a mean age of 70 years (range 23-87 years) were recruited, including 16 men, with a mean hemoglobin of 97 g/L. Initial hemostasis was successful in 19 (95.0%) patients, including 90.0% (9/10) in the TC-325 group and 100% (10/10) in the CCT group. TC-325 monotherapy failed to stop bleeding in a patient with Forrest IB posterior duodenal wall ulcer. Rebleeding was seen in 33.3% (3/9) of the patients in the TC-325 group and 10.0% (1/10) in the CCT group. One patient required angio-embolization therapy while three had successful conventional endotherapy. Two patients from the TC-325 group had serious adverse events that were not procedure- or therapy-related. In patients with Forrest IIA or IIB ulcers, five received TC-325 monotherapy; none had rebleeding.

Our pilot study showed that TC-325 has a tendency towards a higher rebleeding rate than CCT, when treating actively bleeding ulcers. Larger trials are necessary for definitive results.

Peptic ulcer bleeding is treated using endoscopic hemostasis using clips or bands. Pancreas divisum (PD), a congenital anomaly of the pancreas, usually has no clinical symptoms; however, pancreatitis may occur if there are disturbances in the drainage of pancreatic secretions. We report an unusual case of PD accompanied by acute pancreatitis, following endoscopic band ligation for duodenal ulcer bleeding. A 48-year-old woman was admitted to our hospital due to melena. An upper endoscopy revealed a small ulcer with oozing adjacent minor papilla. An endoscopic band ligation was performed on this lesion. Acute pancreatitis developed suddenly 6 hours after the band ligation and improved dramatically after removal of the band. Magnetic resonance cholangiopancreatography was performed, revealing complete PD. Endoscopic band ligation is known as the effective method for peptic ulcer bleeding; however, it should be used carefully in duodenal ulcer bleeding near the minor duodenal papilla due to the possibility of PD.