Stent misdeployment (SMD) is a feared and poorly characterized technical challenge of endoscopic ultrasound (EUS)-guided choledochoduodenostomy (CDS) using lumen-apposing stents. We aimed to ascertain the rate of stent misdeployment in EUS-CDS for malignant distal biliary obstruction (MDBO) and describe its outcomes while identifying variables associated with its occurrence.

 This was a post hoc analysis of two randomized controlled trials comparing EUS-CDS vs. endoscopic retrograde cholangiopancreatography in MDBO. The primary end point was rate of SMD, classified as misdeployment of the distal flange (type I), proximal flange (type II), contralateral bile duct wall injury (type III), or double mucosal puncture (type IV). Multivariable analysis was performed to identify variables associated with SMD and/or technical failure, and with clinical failure or stent dysfunction.

 152 patients were included. Technical success was 93.4 %. SMD occurred in 11 patients (7.2 %; 95 %CI 3.1 %-11.4 %): 8 type I, 1 type II, and 2 type III. Endoscopic salvage of SMD was successful in 81.8 %. Misdeployment led to adverse events in four patients (two mild, two moderate), giving an overall SMD-related adverse event rate of 2.6 % (95 %CI 0.7 %-6.6 %). On multivariable analysis, extrahepatic bile duct diameter of ≤ 15 mm was associated with increased odds of SMD and/or technical failure.

 SMD was relatively common in EUS-CDS and was associated with an extrahepatic bile duct diameter of ≤ 15 mm. The majority of misdeployments could be rescued endoscopically with low risk for adverse events.

Malignant double obstruction, defined as the simultaneous presence of biliary and gastric outlet obstruction, represents a challenging clinical scenario. Previous retrospective experiences have demonstrated shorter dysfunction-free survival (DyFS) of endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) versus EUS-hepaticogastrostomy (EUS-HGS) in this setting, but no prospective evidence is available.

Twenty consecutive patients with malignant double obstruction, treated with EUS-gastroenterostomy (and EUS-guided biliary drainage, following a previously failed ERCP, were enrolled in a prospective observational study (ClinicalTrials.gov NCT04813055) comparing EUS-CDS versus EUS-HGS. Efficacy and safety were evaluated, with Biliary Dysfunctions as the primary outcome and DyFS using Kaplan-Meier estimates as a primary measure.

Twenty patients (75% with pancreatic cancer, 50% with metastatic disease) with EUS-gastroenterostomy were included (seven EUS-CDS and 13 EUS-HGS). No significant difference was detected at baseline. Technical success was 100% in both groups. EUS-CDS compared to EUS-HGS showed similar clinical success (100% vs. 92.3%, p = 0.5), a higher rate of post-procedural adverse events (42.9% vs. 7.7%, p = 0.067, mostly related to severe/fatal cholangitis in the EUS-CDS group) and a higher rate of biliary dysfunctions during follow-up (71.4% vs. 16.7%, p = 0.002).DyFS was significantly shorter in the EUS-CDS group (39 [15-62] vs. 268 [192-344] days, p = 0.0023), with a 30-days DyFS probability of 57.1% vs. 100% (hazard ratio = 7.8 [1.4-44.2]).

In this prospective comparison of patients with malignant double obstruction undergoing EUS-gastroenterostomy, treating jaundice with EUS-CDS versus EUS-HGS resulted in a reduced probability of survival without biliary events and an increased risk of biliary dysfunctions (number needed to harm = 1.8), with detection of severe/fatal cholangitis.

Endoscopic ultrasound (EUS)-guided interventions have revolutionized the management of malignant biliary obstruction (MBO) and gastric outlet obstruction (GOO), providing minimally invasive alternatives with improved outcomes. These procedures have significantly reduced the need for high-risk surgical interventions or percutaneous alternatives and have provided effective palliative care for patients with advanced gastrointestinal and bilio-pancreatic malignancies. EUS-guided biliary drainage (EUS-BD) techniques, including hepaticogastrostomy (EUS-HGS), choledochoduodenostomy (EUS-CDS), and antegrade stenting (EUS-AS), offer high technical and clinical success rates, with a good safety profile particularly when Endoscopic Retrograde Cholangiopancreatography (ERCP) is not feasible. EUS-HGS, which allows biliary drainage by trans-gastric route, is primarily used for proximal stenosis or in case of surgically altered anatomy; EUS-CDS with Lumen-Apposing Metal Stent (LAMS) for distal MBO (dMBO), EUS-AS as an alternative of EUS-HGS in the bridge-to-surgery scenario or when retrograde access is not possible and EUS-guided gallbladder drainage (EUS-GBD) with LAMS in case of dMBO with cystic duct patent without dilation of common bile duct (CDB). EUS-guided gastroenterostomy (EUS-GE) has already established its role as an effective alternative to surgical GE and enteral self-expandable metal stent, providing relief from GOO with fewer complications and faster recovery times. However, we do not yet have strong evidence on how to combine the different EUS-guided drainage techniques with EUS-GE in the setting of double obstruction. This comprehensive review aims to synthesize growing evidence on this topic by randomized controlled trials, cohort studies, and case series not only to summarize the efficacy, safety, and technical aspects of these procedures but also to propose a treatment algorithm based essentially on the anatomy and stage of the neoplasm to guide clinical decision-making, incorporating the principles of personalized medicine. This review also highlights the transformative impact of EUS-guided interventions on the treatment landscape for MBO and GOO. These techniques offer safer and more effective options than traditional approaches, with the potential for widespread clinical adoption. Further research is needed to refine these procedures, expand their applications, and improve patient care and quality of life.

In patients with malignant distal biliary obstruction, drainage via Endoscopic Ultrasound-guided Choledochoduodenostomy (EUS-CDS) is indicated in clinical guidelines following a failed Endoscopic Retrograde Cholangiopancreatography (ERCP). However, current interest lies in evaluating its role as a first-line treatment. Through this letter, we present a case report that represents this clinical scenario, as well as a brief summary of the most recent literature supporting the use of EUS-CDS as a first-line treatment for malignant distal biliary obstruction.

The study aimed to develop international consensus recommendations on the safe use of lumen-apposing metal stents (LAMSs) for on- and off-label indications.

Based on the available literature, statements were formulated and grouped into the following categories: general safety measures, peripancreatic fluid collections, endoscopic ultrasound (EUS)-biliary drainage, EUS-gallbladder drainage, EUS-gastroenterostomy, and gastric access temporary for endoscopy. The evidence level of each statement was determined using the Grading of Recommendations Assessment, Development, and Evaluation methodology.International LAMS experts were invited to participate in a modified Delphi process. When no 80% consensus was reached, the statement was modified based on expert feedback. Statements were rejected if no consensus was reached after the third Delphi round.

Fifty-six (93.3%) of 60 formulated statements were accepted, of which 35 (58.3%) in the first round. Consensus was reached on the optimal learning path, preprocedural imaging, the need for airway protection and essential safety measures during the procedure, such as the use of Doppler, and measurement of the distance between the gastrointestinal lumen and the target structure. Specific consensus recommendations were generated for the different LAMS indications, covering, among others, careful patient selection, the preferred size of the LAMS, the need for antibiotics, the preferred anatomic location of the LAMS, the need for coaxial pigtail placement, and the appropriate management of LAMS-related adverse events.

Through a modified international Delphi process, we developed general and indication-specific experience- and evidence-based recommendations on the safe use of LAMS.

Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) with lumen apposing metal stent is emerging both as a rescue strategy and a primary treatment for distal malignant biliary obstruction. The large-scale diffusion of the procedure and improved overall survival of patients with pancreatobiliary neoplasms is resulting in a growing population of long-term EUS-CDS lumen apposing metal stent carriers. Recent studies have reported a need for reintervention during follow-up as high as 55%, and the Leuven-Amsterdam-Milan Study Group classification has been developed, identifying five mechanisms of stent dysfunction and 11 possible rescue strategies aimed at restoring biliary drainage. This illustrated technical review aims to further dissect the recent classification through a comprehensive analysis of nine illustrative cases, offering insights into the pathophysiology underlying dysfunction and clinical reasoning behind rescue interventions, as well as technical considerations and practical tips and tricks. By exploring mechanisms of dysfunction, this review also assists clinicians in selecting the ideal candidates for EUS-CDS while identifying patients deemed high risk for dysfunction or clinical failure.

Endoscopic ultrasound-guided biliary drainage using electrocautery-enhanced (ECE) delivery of lumen-apposing metal stent (LAMS) is gradually being recognized as a viable palliative technique for malignant biliary obstruction after endoscopic retrograde cholangiopancreatography (ERCP) failure. However, most of the studies that have assessed its efficacy and safety were small and heterogeneous. Prior meta-analyses of six or fewer studies that were published 2 years ago were therefore underpowered to yield convincing evidence.

To update the efficacy and safety of ECE-LAMS for treatment of biliary obstruction after ERCP failure.

We searched PubMed, EMBASE, and Scopus databases from the inception of the ECE technique to May 13, 2022. Primary outcome measure was pooled technical success rate, and secondary outcomes were pooled rates of clinical success, reintervention, and adverse events. Meta-analysis was performed using a random-effects model following Freeman-Tukey double-arcsine transformation in R software (version 4.1.3).

Fourteen eligible studies involving 620 participants were ultimately included. The pooled rate of technical success was 96.7%, and clinical success was 91.0%. Adverse events were reported in 17.5% of patients. Overall reintervention rate was 7.3%. Subgroup analyses showed results were generally consistent.

ECE-LAMS has favorable success with acceptable adverse events in relieving biliary obstruction when ERCP is impossible. The consistency of results across most subgroups suggested that this is a generalizable approach.

Malignant distal biliary obstructions are becoming increasingly common, especially in patients with cancers of the pancreatic head, despite progress in medical oncology research. ERCP is the current gold standard for management of such strictures, but the emergence of EC-LAMS has rendered EUS-CDS both safe and efficient. It is a "game changer"; originally intended for ERCP failure, two randomised clinical trials recently proposed EUS-CDS as a first-intent procedure in palliative settings. For resectable diseases, the absence of iatrogenic pancreatitis associated with a lower rate of postsurgical adverse events (compared with ERCP) leads us to believe that EUS-CDS might be used in first-intent as a pre-operative endoscopic biliary drainage.

Quality improvement through the registration of endoscopy-related adverse events (AEs) has been recognized by major international endoscopy societies as an important quality indicator. The theory behind this is easier to approve than its implementation in daily practice. The results of many valuable attempts have been published in the literature, mainly highlighting the diverse hurdles trying to capture events related to endoscopy and the sedation used for endoscopic procedures. The current review discusses the difficulties encountered attempting to register AEs and incidents related to endoscopic procedures. Government-driven and financed health-care databases with automated coupling of specific data seem the only efficient way to implement endoscopy-related AEs and outcomes on a prospective and complete basis. This will not only allow continuous confidential feedback to endoscopists in relation to the pooled national benchmark data, but also follow-up in time through data-driven credentialing aiming to progressively optimize these benchmark data.

Aim: The lumen-apposing metal stent (LAMS) is a new device that expands the scope of gastrointestinal intervention under endoscopy. LAMS was initially used for the treatment of pancreatic fluid collections (PFCs), but is increasingly being used off-label. The electrocautery system simplifies the deployment of LAMS, making it more suitable for off-label situations. The short-term results of electrocautery-enhanced lumen-apposing metal stents (ECE-LAMS) are satisfactory; however, the long-term follow-up results must be evaluated. The aim of this article is to review the expanded clinical application of ECE-LAMS, the clinical value of on-label and off-label use, and follow-up results.Methods: After searching in PubMed and Web of Science databases using 'electrocautery-enhanced lumen-apposing metal stents' and 'endoscopic ultrasonography (EUS) -guided interventions' as keywords, studies related were compiled and examined.Results: ECE-LAMS are widely used for on-label and off-label situations. The short-term and long-term results of ECE-LAMS are satisfactory, but there are still some studies that do not agree with this viewpoint.Conclusion: The clinical application of ECE-LAMS is relatively safe and reliable but more well-designed randomized trials and prospective studies are needed to evaluate the impact of this technology on therapeutic EUS, to improve the safety and success rate of EUS-guided LAMS implantation, and to expand its application in other indications.

Multiple meta-analyses have evaluated the technical and clinical success of EUS-guided biliary drainage (BD), but meta-analyses concerning adverse events (AEs) are limited. The present meta-analysis analyzed AEs associated with various types of EUS-BD.

A literature search of MEDLINE, Embase, and Scopus was conducted from 2005 to September 2022 for studies analyzing the outcome of EUS-BD. The primary outcomes were incidence of overall AEs, major AEs, procedure-related mortality, and reintervention. The event rates were pooled using a random-effects model.

One hundred fifty-five studies (7887 patients) were included in the final analysis. The pooled clinical success rates and incidence of AEs with EUS-BD were 95% (95% confidence interval [CI], 94.1-95.9) and 13.7% (95% CI, 12.3-15.0), respectively. Among early AEs, bile leak was the most common followed by cholangitis with pooled incidences of 2.2% (95% CI, 1.8-2.7) and 1.0% (95% CI, .8-1.3), respectively. The pooled incidences of major AEs and procedure-related mortality with EUS-BD were .6% (95% CI, .3-.9) and .1% (95% CI, .0-.4), respectively. The pooled incidences of delayed migration and stent occlusion were 1.7% (95% CI, 1.1-2.3) and 11.0% (95% CI, 9.3-12.8), respectively. The pooled event rate for reintervention (for stent migration or occlusion) after EUS-BD was 16.2% (95% CI, 14.0-18.3; I2 = 77.5%).

Despite a high clinical success rate, EUS-BD may be associated with AEs in one-seventh of the cases. However, major AEs and mortality incidence remain less than 1%, which is reassuring.

EUS-guided interventions have become widely accepted therapeutic management options for drainage of peripancreatic fluid collections. Apart from endosonographic skills, EUS interventions require knowledge of the endoscopic stenting techniques and familiarity with the available stents and deployment systems. Although generally safe and effective, technical failure of correct stent positioning or serious adverse events can occur, even in experts' hands. In this article, we address common and rare adverse events in transmural EUS-guided stenting, ways to prevent them, and management options when they occur. Knowing the risks of what can go wrong combined with clinical expertise, high levels of technical skills, and adequate training allows for the safe performance of EUS-guided drainage procedures. Discussing the procedural risks and their likelihood with the patient is a fundamental part of the consenting process.

Malignant biliary obstruction (DMBO) has been traditionally managed by endoscopic retrograde cholangiopancreatography (ERCP). In the case of ERC failure, percutaneous transhepatic biliary drainage (PT-BD) has been widely utilized as a salvage procedure. However, over the last decade, endoscopic ultrasound-guided biliary drainage (EUS-BD) has gained increasing popularity, especially after the advent of electrocautery-enhanced lumen apposing metal stent devices (EC-LAMSs) which enable a one-step procedure, granting prevention of biliary leakage and minimizing occurrence of adverse events (AEs). In parallel, increasing evidence suggests a possible role of EUS-BD in the management of DMBO as a primary palliative drainage modality. In the current paper, we aim to review all the available evidence on the role of EUS-BD performed with EC-LAMSs and discuss salient technical aspects of this type of procedure.

Long-term outcomes of endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) performed with lumen apposing metal stents (LAMS) have been poorly evaluated in small or retrospective series, leading to an underestimation of LAMS dysfunction.

All consecutive EUS-CDS performed in three academic referral centers were included in prospectively maintained databases. Technical/clinical success, adverse events (AEs), and dysfunction during follow-up were retrospectively analyzed. Kaplan-Meier analysis was used to estimate dysfunction-free survival (DFS), with Cox proportional hazard regression to evaluate independent predictors of dysfunction.

Ninety-three patients were included (male 56%; mean age, 70 years [95% confidence interval (CI) 68-72]; pancreatic cancer 81%, metastatic disease 47%). In 67% of procedures, 6 mm LAMS were used. Technical and clinical success were achieved in 97.8% and 93.4% of patients, respectively, with AEs occurring in 9.7% (78% mild/moderate). Dysfunction occurred in 31.8% of patients after a mean of 166 days (95% CI 91-241), with an estimated 6 month and 12 month DFS of 75% and 52%, respectively; mean DFS of 394 (95% CI 307-482) days. Almost all dysfunctions (96%) were successfully managed by endoscopic reintervention. Duodenal invasion (hazard ratio 2.7 [95% CI 1.1-6.8]) was the only independent predictor of dysfunction.

Endoscopic ultrasound-guided choledochoduodenostomy shows excellent initial efficacy and safety, although stent dysfunctions occurs frequently during long-term follow-up. Almost all stent dysfunctions can be managed successfully by endoscopic reinterventions. We propose a comprehensive classification of the different types of dysfunction that may be encountered and rescue procedures that may be employed under these circumstances. Duodenal invasion seems to increase the risk of developing EUS-CDS dysfunction, potentially representing a relative contraindication for this technique.

EUS-guided choledoco-duodenostomy using electrocautery-enhanced lumen-apposing metal stents (ECE-LAMS) is becoming the gold standard in case of endoscopic retrograde cholangio-pancreatography failure for distal malignant obstruction. Long-term data in larger samples are lacking.

This was a prospective monocentric study including all patients who underwent EUS-guided choledochoduodenostomy (CDS) between September 2016 and December 2021. The primary endpoint was the rate of biliary obstruction during follow-up. Secondary endpoints were technical and clinical success rates, adverse event rates, and identification of risk factors for biliary obstruction.

One hundred and twenty-three EUS-guided CDS using ECE-LAMS were performed at Limoges University Hospital were performed during the study period and included in the study. The main cause of obstruction was pancreatic adenocarcinoma in 91 (74.5%) cases. The technical and clinical success rates were 97.5% and 91%, respectively. Twenty patients (16.3%) suffered from biliary obstructions during a mean follow-up of 242 days. The clinical success rate for endoscopic desobstruction was 80% (16/20). In uni- and multivariate analyses, only the presence of a duodenal stent (odds ratio [OR]: 3.6, 95% confidence interval [CI] 95%: 1.2-10.2; P = 0.018) and a bile duct thinner than 15 mm (OR: 3.9, CI 95%: 1.3-11.7; P = 0.015) were the significant risk factors for biliary obstruction during the follow-up.

Obstruction of LAMS occurred in 16.3% of cases during follow-up and endoscopic desobstruction is efficacious in 80% of cases. The presence of duodenal stent and a bile duct thinner than 15 mm are the risk factors of obstruction. Except in these situation, EUS-CDS with ECE-LAMS could be proposed in the first intent in case of distal malignant obstruction.

Lumen-apposing metal stents (LAMSs) are increasingly used both for on- and off-label indications. We continuously adapt our step-by-step protocol to optimize the safe deployment of LAMSs for the different indications. The aim of this study was to evaluate the impact of this approach over time.

We conducted a single-center study on consecutive patients who underwent LAMS placement for on- and off-label indications between June 2020 and June 2022. Endpoints included technical success, clinical success and adverse event rates. We compared the results with our previously published early experience with LAMSs (N = 61), between March 2018 and May 2020.

This cohort consisted of 168 LAMSs in 153 patients. Almost half of them (47.6%) were placed for off-label indications (gastro-enterostomy, temporary access to the excluded stomach in patients with previous gastric bypass, drainage of postsurgical collections, stenting of short refractory gastrointestinal strictures). While the technical and clinical success rates were similar to those in our previously published cohort (97% and 93.5% versus 93.4% and 88.5%, respectively), the adverse event rate dropped from 21.3% to 8.9%.

Our results demonstrate the impact of a learning curve in LAMS placement, with a clinically relevant drop in LAMS-related adverse events over time.