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Fatakhova K, Inayat F, Ali H, Patel P, Rehman AU, Afzal A, Sarfraz M, Sarfraz S, Nawaz G, Chaudhry A, Dhillon R, Dilibe A, Glazebnik B, Jones L, Glazer E. Gender disparities and woman-specific trends in Barrett's esophagus in the United States: An 11-year nationwide population-based study. World J Methodol 2025; 15:97512. [PMID: 40115400 PMCID: PMC11525896 DOI: 10.5662/wjm.v15.i1.97512] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/31/2024] [Revised: 07/25/2024] [Accepted: 07/29/2024] [Indexed: 09/29/2024] Open
Abstract
BACKGROUND Barrett's esophagus (BE) is a known premalignant precursor to esophageal adenocarcinoma (EAC). The prevalence rates continue to rise in the United States, but many patients who are at risk of EAC are not screened. Current practice guidelines include male gender as a predisposing factor for BE and EAC. The population-based clinical evidence regarding female gender remains limited. AIM To study comparative trends of gender disparities in patients with BE in the United States. METHODS A nationwide retrospective study was conducted using the 2009-2019 National Inpatient Sample (NIS) database. Patients with a primary or secondary diagnosis code of BE were identified. The major outcome of interest was determining the gender disparities in patients with BE. Trend analysis for respective outcomes for females was also reported to ascertain any time-based shifts. RESULTS We identified 1204190 patients with BE for the study period. Among the included patients, 717439 (59.6%) were men and 486751 (40.4%) were women. The mean age was higher in women than in men (67.1 ± 0.4 vs 66.6 ± 0.3 years, P < 0.001). The rate of BE per 100000 total NIS hospitalizations for males increased from 144.6 in 2009 to 213.4 in 2019 (P < 0.001). The rate for females increased from 96.8 in 2009 to 148.7 in 2019 (P < 0.001). There was a higher frequency of obesity among women compared to men (17.4% vs 12.6%, P < 0.001). Obesity prevalence among females increased from 12.3% in 2009 to 21.9% in 2019 (P < 0.001). A lower prevalence of smoking was noted in women than in men (20.8% vs 35.7%, P < 0.001). However, trend analysis showed an increasing prevalence of smoking among women, from 12.9% in 2009 to 30.7% in 2019 (P < 0.001). Additionally, there was a lower prevalence of alcohol abuse, Helicobacter pylori (H. pylori), and diabetes mellitus among females than males (P < 0.001). Trend analysis showed an increasing prevalence of alcohol use disorder and a decreasing prevalence of H. pylori and diabetes mellitus among women (P < 0.001). CONCLUSION The prevalence of BE among women has steadily increased from 2009 to 2019. The existing knowledge concerning BE development has historically focused on men, but our findings show that the risk in women is not insignificant.
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Affiliation(s)
- Karina Fatakhova
- Division of Gastroenterology and Hepatology, Mather Hospital and Zucker School of Medicine at Hofstra University, Port Jefferson, NY 11777, United States
| | - Faisal Inayat
- Department of Internal Medicine, Allama Iqbal Medical College, Lahore, Punjab 54550, Pakistan
| | - Hassam Ali
- Division of Gastroenterology and Hepatology, East Carolina University Brody School of Medicine, Greenville, NC 27834, United States
| | - Pratik Patel
- Division of Gastroenterology and Hepatology, Mather Hospital and Zucker School of Medicine at Hofstra University, Port Jefferson, NY 11777, United States
| | - Attiq Ur Rehman
- Division of Gastroenterology and Hepatology, Geisinger Wyoming Valley Medical Center, Wilkes-Barre, PA 18711, United States
| | - Arslan Afzal
- Division of Gastroenterology and Hepatology, East Carolina University Brody School of Medicine, Greenville, NC 27834, United States
| | - Muhammad Sarfraz
- Division of Gastroenterology and Hepatology, Geisinger Wyoming Valley Medical Center, Wilkes-Barre, PA 18711, United States
| | - Shiza Sarfraz
- Department of Internal Medicine, East Carolina University Brody School of Medicine, Greenville, NC 27834, United States
| | - Gul Nawaz
- Department of Internal Medicine, Allama Iqbal Medical College, Lahore, Punjab 54550, Pakistan
| | - Ahtshamullah Chaudhry
- Department of Internal Medicine, St. Dominic's Hospital, Jackson, MS 39216, United States
| | - Rubaid Dhillon
- Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic Foundation, Cleveland, OH 44195, United States
| | - Arthur Dilibe
- Department of Internal Medicine, East Carolina University Brody School of Medicine, Greenville, NC 27834, United States
| | - Benjamin Glazebnik
- Department of Internal Medicine, Mather Hospital and Hofstra University Zucker, School of Medicine, Port Jefferson, NY 11777, United States
| | - Lindsey Jones
- Department of Internal Medicine, Mather Hospital and Hofstra University Zucker, School of Medicine, Port Jefferson, NY 11777, United States
| | - Emily Glazer
- Division of Gastroenterology and Hepatology, Mather Hospital and Zucker School of Medicine at Hofstra University, Port Jefferson, NY 11777, United States
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Wani S, Cote GA, Keswani RN, Yadlapati RH, Hall M, O'Hara J, Berzin TM, Burbridge RA, Chahal P, Cohen J, Coyle WJ, Early D, Guda NM, Inamdar S, Khanna L, Kulkarni A, Rosenkranz L, Sharma N, Shin EJ, Siddiqui UD, Sinha J, Vanderveldt H, Draganov PV. Development of American Society for Gastrointestinal Endoscopy standards for training in advanced endoscopy within dedicated advanced endoscopy fellowship programs. Gastrointest Endosc 2025; 101:12-24. [PMID: 38935016 DOI: 10.1016/j.gie.2024.03.025] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/14/2024] [Accepted: 03/18/2024] [Indexed: 06/28/2024]
Abstract
BACKGROUND AND AIMS Training in interventional endoscopy is offered by nonaccredited advanced endoscopy fellowship programs (AEFPs). The number of these programs has increased dramatically with a concurrent increase in the breadth and complexity of interventional endoscopy procedures. Accreditation is governed by competency-based education, yet what constitutes a "high-quality" nonaccredited AEFP has not been defined. Using an evidence-based consensus process, we aimed to establish standards for AEFPs. METHODS The RAND UCLA appropriateness method, a well-described modified Delphi process to develop quality indicators, was used. A task force established by the American Society for Gastrointestinal Endoscopy drafted potential quality indicators (structure, process, and outcome) in 6 categories: activity preceding training; structure of AEFPs; training in ERCP, EUS, and EMR; and luminal stent placement. Three rounds of iterative feedback from 20 experts were conducted. Round 0 involved discussion of project details. In round 1, experts independently ranked proposed quality indicators on a 9-point interval scale ranging from highly inappropriate (1) to highly appropriate (9). Next, proposed quality indicators were discussed and reworded in a group meeting followed by round 2, in which experts independently reranked proposed quality indicators and provided benchmarks (when applicable). The median score for each quality indicator was calculated. Mean absolute deviation from the median was calculated, and appropriateness of potential quality indicators was assessed using the BIOMED concerted action on appropriateness definition, P value method, and interpercentile range adjusted for symmetry definition. A quality indicator was deemed appropriate if the median score was ≥7 and met criteria for appropriateness using all 3 defined statistical methods. RESULTS Of 89 proposed quality indicators, 37 statements met criteria as appropriate for a quality indicator (activity preceding training, 2; structure of AEFPs, 10; training in ERCP, 7; training in EUS, 8; training in EMR, 7; luminal stent placement, 3). Minimum thresholds were defined for 19 relevant quality indicators for number of trainers, procedures during fellowship, and procedures before assessment of competence. Among the final appropriate quality indicators were that all trainees should undergo qualitative and quantitative competence assessments using validated tools at least quarterly with documented feedback throughout the training period and that trainees should track outcomes and relevant quality metrics for specific procedures. CONCLUSIONS This consensus process using validated methodology established standards for an AEFP in an effort to ensure adequate training in the most commonly taught interventional endoscopic procedures (ERCP, EUS, EMR, and luminal stent placement) during fellowship. An important component of an AEFP is the use of competency-based assessments that are compliant with the Accreditation Council for Graduate Medical Education's Next Accreditation System, with the goal of ensuring that trainees achieve specific milestones in their progression to achieving cognitive and technical competency.
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Affiliation(s)
- Sachin Wani
- Division of Gastroenterology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA
| | - Gregory A Cote
- Division of Gastroenterology, Oregon Health & Science University, Portland, Oregon, USA
| | - Rajesh N Keswani
- Division of Gastroenterology and Hepatology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
| | - Rena H Yadlapati
- UCSD Center for Esophageal Diseases, Division of Gastroenterology, University of California San Diego, La Jolla, California, USA
| | - Matt Hall
- Children's Hospital Association, Lenexa, Kansas, USA
| | - Jack O'Hara
- Division of Gastroenterology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA
| | - Tyler M Berzin
- Beth Israel Deaconess Medical Center, Division of Gastroenterology, Harvard Medical School, Boston, Massachusetts, USA
| | - Rebecca A Burbridge
- Division of Gastroenterology, Duke University Medical Center, Durham, North Carolina, USA
| | - Prabhleen Chahal
- Department of Gastroenterology and Hepatology, Digestive Disease Institute, Cleveland Clinic, Cleveland, Ohio, USA
| | - Jonathan Cohen
- New York University Grossman School of Medicine, New York, New York, USA
| | - Walter J Coyle
- Division of Gastroenterology, Scripps Green Hospital, La Jolla, California, USA
| | - Dayna Early
- Division of Gastroenterology, Washington University School of Medicine, St Louis, Missouri, USA
| | - Nalini M Guda
- Aurora St Luke's Medical Center, Milwaukee, Wisconsin, USA
| | - Sumant Inamdar
- Division of Gastroenterology, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA
| | - Lauren Khanna
- Department of Medicine, New York University Langone Health, New York, New York, USA
| | - Abhijit Kulkarni
- Division of Gastroenterology and Hepatology, Allegheny Health Network, Pittsburgh, Pennsylvania, USA
| | - Laura Rosenkranz
- Division of Gastroenterology, Hepatology, and Nutrition, University of Texas Health, San Antonio, Texas, USA
| | - Neil Sharma
- Division of Interventional Endoscopic Oncology and Surgical Endoscopy, Parkview Health, Fort Wayne, Indiana, USA
| | - Eun Ji Shin
- Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA
| | - Uzma D Siddiqui
- Center for Endoscopic Research and Therapeutics (CERT), University of Chicago, Chicago, Illinois, USA; 20Division of Gastroenterology, Northwestern University, Chicago, Illinois, USA
| | - Jasmine Sinha
- Division of Gastroenterology and Hepatology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
| | - Hendrikus Vanderveldt
- Department of Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA
| | - Peter V Draganov
- Division of Gastroenterology, Hepatology and Nutrition, Department of Medicine, University of Florida, Gainesville, Florida, USA
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Xu W, McGuinness MJ, Wells C, Varghese C, Elliott B, Paterson L, Collins R, Lill M, Windsor J, Koea J, Panoho J, Walmsley R, Wright D, Parry S, Harmston C. Protocol for a national, multicentre study of post-endoscopy colorectal and upper gastrointestinal cancers: The POET study. Colorectal Dis 2024; 26:1720-1731. [PMID: 38978156 DOI: 10.1111/codi.17057] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/13/2024] [Accepted: 05/18/2024] [Indexed: 07/10/2024]
Abstract
AIM The primary aim of the study is to define the post-colonoscopy colorectal cancer (PCCRC) three-year rate and the post-endoscopy upper gastrointestinal cancer (PEUGIC) three-year rate across public hospitals in Aotearoa New Zealand. METHOD This retrospective cohort study will be conducted via the trainee-led STRATA Collaborative network. All public hospitals in Aotearoa New Zealand will be eligible to participate. Data will be collected on all adult patients who are diagnosed with colorectal adenocarcinoma within 6 to 48 months of a colonoscopy and all adult patients diagnosed with gastroesophageal cancer within 6 to 48 months of an upper gastrointestinal endoscopy. The study period will be from 2010 to 2022. The primary outcome is the PCCRC 3-year rate and the PEUGIC 3-year rate. Secondary aims are to define and characterize survival after PCCRC or PEUGIC, the cause of PCCRC as based on the World Endoscopy Organization System of Analysis definitions, trends over time, and centre level variation. CONCLUSION This protocol describes the methodology for a nationwide retrospective cohort study on PCCRC and PEUGIC in Aotearoa New Zealand. These data will lay the foundation for future studies and quality improvement initiatives.
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Affiliation(s)
- William Xu
- Department of Surgery, Whangārei Hospital, Te Whatu Ora, Whangārei, New Zealand
- Department of Surgery, University of Auckland, Auckland, New Zealand
| | - Matthew James McGuinness
- Department of Surgery, University of Auckland, Auckland, New Zealand
- Department of Surgery, North Shore Hospital, Te Whatu Ora, Auckland, New Zealand
| | - Cameron Wells
- Department of Surgery, University of Auckland, Auckland, New Zealand
- Department of Surgery, Hawke's Bay Hospital, Te Whatu Ora, Hastings, New Zealand
| | - Chris Varghese
- Department of Surgery, University of Auckland, Auckland, New Zealand
- Department of Surgery, Middlemore Hospital, Te Whatu Ora, Auckland, New Zealand
| | - Brodie Elliott
- Department of Surgery, Whangārei Hospital, Te Whatu Ora, Whangārei, New Zealand
- Department of Surgery, University of Auckland, Auckland, New Zealand
| | - Luke Paterson
- Department of Surgery, Whangārei Hospital, Te Whatu Ora, Whangārei, New Zealand
| | - Ray Collins
- Department of Surgery, Middlemore Hospital, Te Whatu Ora, Auckland, New Zealand
| | - Marianne Lill
- New Zealand Association of General Surgeons, New Zealand
- Department of Surgery, Whanganui Hospital, Te Whatu Ora, Whanganui, New Zealand
| | - John Windsor
- Department of Surgery, University of Auckland, Auckland, New Zealand
| | - Jonathan Koea
- Department of Surgery, University of Auckland, Auckland, New Zealand
- Department of Surgery, North Shore Hospital, Te Whatu Ora, Auckland, New Zealand
| | - Joy Panoho
- Te Poutokomanawa, Te Whatu Ora, New Zealand
| | - Russell Walmsley
- Department of Surgery, North Shore Hospital, Te Whatu Ora, Auckland, New Zealand
- Department of Gastroenterology, North Shore Hospital, Te Whatu Ora, Auckland, New Zealand
| | - Deborah Wright
- Department of Surgery, Dunedin Hospital, Te Whatu Ora, Dunedin, New Zealand
- Department of Surgery, University of Otago, Dunedin, New Zealand
| | - Susan Parry
- Department of Gastroenterology, Auckland City Hospital, Te Whatu Ora, Auckland, New Zealand
- Department of Medicine, University of Auckland, Auckland, New Zealand
| | - Christopher Harmston
- Department of Surgery, Whangārei Hospital, Te Whatu Ora, Whangārei, New Zealand
- Department of Surgery, University of Auckland, Auckland, New Zealand
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Yoo JW, Laszkowska M, Mendelsohn RB. The Role of Screening and Early Detection in Upper Gastrointestinal Cancers. Hematol Oncol Clin North Am 2024; 38:693-710. [PMID: 38431494 DOI: 10.1016/j.hoc.2024.01.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 03/05/2024]
Abstract
Upper gastrointestinal cancers are among the leading causes of cancer deaths worldwide with exceptionally poor prognosis, which is largely attributable to frequently delayed diagnosis. Although effective screening is critical for early detection, the highly variable incidence of upper gastrointestinal cancers presents challenges, rendering universal screening programs suboptimal in most populations globally. Optimal strategies in regions of modest incidence, such as the United States, require a targeted approach, focused on high-risk individuals based on demographic, familial, and clinicopathologic risk factors. Assessment of underlying precancerous lesions has key implications for risk stratification and informing clinical decisions to improve patient outcomes.
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Affiliation(s)
- Jin Woo Yoo
- Gastroenterology, Hepatology and Nutrition Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA.
| | - Monika Laszkowska
- Gastroenterology, Hepatology and Nutrition Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA
| | - Robin B Mendelsohn
- Gastroenterology, Hepatology and Nutrition Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA
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5
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Wang K, Wang S, Chen Y, Lu X, Wang D, Zhang Y, Pan W, Zhou C, Zou D. Causal relationship between gut microbiota and risk of gastroesophageal reflux disease: a genetic correlation and bidirectional Mendelian randomization study. Front Immunol 2024; 15:1327503. [PMID: 38449873 PMCID: PMC10914956 DOI: 10.3389/fimmu.2024.1327503] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/25/2023] [Accepted: 02/05/2024] [Indexed: 03/08/2024] Open
Abstract
Background Numerous observational studies have identified a linkage between the gut microbiota and gastroesophageal reflux disease (GERD). However, a clear causative association between the gut microbiota and GERD has yet to be definitively ascertained, given the presence of confounding variables. Methods The genome-wide association study (GWAS) pertaining to the microbiome, conducted by the MiBioGen consortium and comprising 18,340 samples from 24 population-based cohorts, served as the exposure dataset. Summary-level data for GERD were obtained from a recent publicly available genome-wide association involving 78 707 GERD cases and 288 734 controls of European descent. The inverse variance-weighted (IVW) method was performed as a primary analysis, the other four methods were used as supporting analyses. Furthermore, sensitivity analyses encompassing Cochran's Q statistics, MR-Egger intercept, MR-PRESSO global test, and leave-one-out methodology were carried out to identify potential heterogeneity and horizontal pleiotropy. Ultimately, a reverse MR assessment was conducted to investigate the potential for reverse causation. Results The IVW method's findings suggested protective roles against GERD for the Family Clostridiales Vadin BB60 group (P = 0.027), Genus Lachnospiraceae UCG004 (P = 0.026), Genus Methanobrevibacter (P = 0.026), and Phylum Actinobacteria (P = 0.019). In contrast, Class Mollicutes (P = 0.037), Genus Anaerostipes (P = 0.049), and Phylum Tenericutes (P = 0.024) emerged as potential GERD risk factors. In assessing reverse causation with GERD as the exposure and gut microbiota as the outcome, the findings indicate that GERD leads to dysbiosis in 13 distinct gut microbiota classes. The MR results' reliability was confirmed by thorough assessments of heterogeneity and pleiotropy. Conclusions For the first time, the MR analysis indicates a genetic link between gut microbiota abundance changes and GERD risk. This not only substantiates the potential of intestinal microecological therapy for GERD, but also establishes a basis for advanced research into the role of intestinal microbiota in the etiology of GERD.
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Affiliation(s)
- Kui Wang
- Department of Gastroenterology, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
- Department of Gastroenterology, The First People’s Hospital of Yunnan Province, The Affiliated Hospital of Kunming University of Science and Technology, Kunming, Yunnan, China
| | - Suijian Wang
- Department of Endocrinology and Metabolism, First Affiliated Hospital of Stantou University Medical College, Stantou, China
| | - Yuhua Chen
- The First Clinical Medical College, Lanzhou University, Lanzhou, Gansu, China
| | - Xinchen Lu
- Department of Gastroenterology, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
| | - Danshu Wang
- Department of Gastroenterology, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
| | - Yao Zhang
- Department of Gastroenterology, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
| | - Wei Pan
- The First Clinical Medical College, Lanzhou University, Lanzhou, Gansu, China
| | - Chunhua Zhou
- Department of Gastroenterology, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
| | - Duowu Zou
- Department of Gastroenterology, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
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Waddingham W, Graham DG, Banks MR. Latest Advances in Endoscopic Detection of Oesophageal and Gastric Neoplasia. Diagnostics (Basel) 2024; 14:301. [PMID: 38337817 PMCID: PMC10855581 DOI: 10.3390/diagnostics14030301] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/29/2023] [Revised: 01/23/2024] [Accepted: 01/24/2024] [Indexed: 02/12/2024] Open
Abstract
Endoscopy is the gold standard for the diagnosis of cancers and cancer precursors in the oesophagus and stomach. Early detection of upper GI cancers requires high-quality endoscopy and awareness of the subtle features these lesions carry. Endoscopists performing surveillance of high-risk patients including those with Barrett's oesophagus, previous squamous neoplasia or chronic atrophic gastritis should be familiar with endoscopic features, classification systems and sampling techniques to maximise the detection of early cancer. In this article, we review the current approach to diagnosis of these conditions and the latest advanced imaging and diagnostic techniques.
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Affiliation(s)
- William Waddingham
- Department of Gastroenterology, Royal Free London NHS Foundation Trust, London NW3 2QG, UK
| | - David G. Graham
- Department of Gastroenterology, University College London NHS Foundation Trust, London NW1 2BU, UK
| | - Matthew R. Banks
- Department of Gastroenterology, University College London NHS Foundation Trust, London NW1 2BU, UK
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7
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Lebwohl B, Ma C, Lagana SM, Pai RK, Baker KA, Zayadi A, Hogan M, Bouma G, Cellier C, Goldsmith JD, Lundin KEA, Pinto-Sanchez MI, Robert ME, Rubio-Tapia A, Sanders DS, Schaeffer DF, Semrad CE, Silvester JA, Verdú EF, Verma R, Wu TT, Feagan BG, Crowley E, Jairath V, Murray JA. Standardizing Randomized Controlled Trials in Celiac Disease: An International Multidisciplinary Appropriateness Study. Gastroenterology 2024; 166:88-102. [PMID: 37704112 PMCID: PMC12055257 DOI: 10.1053/j.gastro.2023.08.051] [Citation(s) in RCA: 8] [Impact Index Per Article: 8.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/17/2023] [Revised: 08/22/2023] [Accepted: 08/30/2023] [Indexed: 09/15/2023]
Abstract
BACKGROUND & AIMS There is a need to develop safe and effective pharmacologic options for the treatment of celiac disease (CeD); however, consensus on the appropriate design and configuration of randomized controlled trials (RCTs) in this population is lacking. METHODS A 2-round modified Research and Development/University of California Los Angeles Appropriateness Method study was conducted. Eighteen gastroenterologists (adult and pediatric) and gastrointestinal pathologists voted on statements pertaining to the configuration of CeD RCTs, inclusion and exclusion criteria, gluten challenge, and trial outcomes. Two RCT designs were considered, representing the following distinct clinical scenarios for which pharmacotherapy may be used: trials incorporating a gluten challenge to simulate exposure; and trials evaluating reversal of histologic changes, despite attempted adherence to a gluten-free diet. Each statement was rated as appropriate, uncertain, or inappropriate, using a 9-point Likert scale. RESULTS For trials evaluating prevention of relapse after gluten challenge, participants adherent to a gluten-free diet for 12 months or more with normal or near-normal-sized villi should be enrolled. Gluten challenge should be FODMAPS (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) free, and efficacy evaluated using histology with a secondary patient-reported outcome measure. For trials evaluating reversal of villus atrophy, the panel voted it appropriate to enroll participants with a baseline villus height to crypt depth ratio ≤2 and measure efficacy using a primary histologic end point. Guidance for measuring histologic, endoscopic, and patient-reported outcomes in adult and pediatric patients with CeD are provided, along with recommendations regarding the merits and limitations of different end points. CONCLUSIONS We developed standardized recommendations for clinical trial design, eligibility criteria, outcome measures, gluten challenge, and disease evaluations for RCTs in patients with CeD.
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Affiliation(s)
- Benjamin Lebwohl
- Celiac Disease Center, Department of Medicine, Columbia University College of Physicians and Surgeons, New York, New York; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, New York.
| | - Christopher Ma
- Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, Calgary, Alberta, Canada; Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada; Alimentiv Inc, London, Ontario, Canada.
| | - Stephen M Lagana
- Department of Pathology and Cell Biology, Columbia University, New York, New York
| | - Rish K Pai
- Department of Pathology and Laboratory Medicine, Mayo Clinic Arizona, Scottsdale, Arizona
| | | | | | | | - Gerd Bouma
- Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam Gastroenterology Endocrinology Metabolism Research Institute, Amsterdam, The Netherlands
| | - Christophe Cellier
- Department of Gastroenterology, University of Paris-Cité, Georges-Pompidou European Hospital, Assistance Publique des Hôpitaux de Paris, Paris, France
| | | | - Knut E A Lundin
- Norwegian Coeliac Disease Research Centre, University of Oslo Faculty of Medicine, Oslo, Norway; Department of Gastroenterology, Oslo University Hospital Rikshospitalet, Oslo, Norway
| | - Maria I Pinto-Sanchez
- Department of Medicine, Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada
| | - Marie E Robert
- Department of Pathology, Yale University School of Medicine, New Haven, Connecticut
| | - Alberto Rubio-Tapia
- Celiac Disease Program, Division of Gastroenterology, Hepatology, and Nutrition, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, Ohio
| | - David S Sanders
- Academic Unit of Gastroenterology, Royal Hallamshire Hospital, Sheffield, United Kingdom
| | - David F Schaeffer
- Department of Pathology and Laboratory Medicine, Vancouver General Hospital, Vancouver, British Columbia, Canada
| | - Carol E Semrad
- Department of Gastroenterology, University of Chicago, Chicago, Illinois
| | - Jocelyn A Silvester
- Harvard Celiac Research Program, Harvard Medical School, Boston, Massachusetts; Division of Gastroenterology, Department of Pediatrics, Boston Children's Hospital, Boston, Massachusetts; Celiac Disease Center, Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts
| | - Elena F Verdú
- Department of Medicine, Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada
| | - Ritu Verma
- Department of Pediatrics, Section of Gastroenterology, Hepatology and Nutrition, The University of Chicago, Chicago, Illinois
| | - Tsung-Teh Wu
- Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota
| | - Brian G Feagan
- Alimentiv Inc, London, Ontario, Canada; Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada
| | - Eileen Crowley
- Alimentiv Inc, London, Ontario, Canada; Division of Pediatric Gastroenterology, Department of Pediatrics, Children's Hospital Western Ontario, London Health Sciences Centre, Western University, London, Ontario, Canada
| | - Vipul Jairath
- Alimentiv Inc, London, Ontario, Canada; Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada
| | - Joseph A Murray
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota
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Wani S, Holmberg D, Santoni G, Kauppila JH, Farkkila M, von Euler-Chelpin M, Shaheen NJ, Lagergren J. Magnitude and Time-Trends of Post-Endoscopy Esophageal Adenocarcinoma and Post-Endoscopy Esophageal Neoplasia in a Population-Based Cohort Study: The Nordic Barrett's Esophagus Study. Gastroenterology 2023; 165:909-919.e13. [PMID: 37279832 DOI: 10.1053/j.gastro.2023.05.044] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/23/2023] [Revised: 04/12/2023] [Accepted: 05/14/2023] [Indexed: 06/08/2023]
Abstract
BACKGROUND & AIMS Post-endoscopy esophageal adenocarcinoma (PEEC) and post-endoscopy esophageal neoplasia (PEEN) undermine early cancer detection in Barrett's esophagus (BE). We aimed to assess the magnitude and conduct time-trend analysis of PEEC and PEEN among patients with newly diagnosed BE. METHODS This population-based cohort study was conducted in Denmark, Finland, and Sweden between 2006 and 2020 and included 20,588 patients with newly diagnosed BE. PEEC and PEEN were defined as esophageal adenocarcinoma (EAC) or high-grade dysplasia (HGD)/EAC, respectively, diagnosed 30-365 days from BE diagnosis (index endoscopy). HGD/EAC diagnosed from 0-29 days and HGD/EAC diagnosed >365 days from BE diagnosis (incident HGD/EAC) were assessed. Patients were followed up until HGD/EAC, death, or end of study period. Incidence rates (IR) per 100,000 person-years with 95% confidence interval (95% CI) were calculated using Poisson regression. RESULTS Among 293 patients diagnosed with EAC, 69 (23.5%) were categorized as PEEC, 43 (14.7%) as index EAC, and 181 (61.8%) as incident EAC. The IRs/100,000 person-years for PEEC and incident EAC were 392 (95% CI, 309-496), and 208 (95% CI, 180-241), respectively. Among 279 patients diagnosed with HGD/EAC (Sweden only), 17.2% were categorized as PEEN, 14.6% as index HGD/EAC, and 68.1% as incident HGD/EAC. IRs/100,000 person-years for PEEN, and incident HGD/EAC were 421 (95% CI, 317-558), and 285 (95% CI, 247-328), respectively. Sensitivity analyses that varied time interval for occurrence of PEEC/PEEN demonstrated similar results. A time-trend analysis for IRs demonstrated rising incidence rates of PEEC/PEEN. CONCLUSIONS Almost a quarter of all EACs are detected within a year after an ostensibly negative upper endoscopy in patients with newly diagnosed BE. Interventions to improve detection may reduce PEEC/PEEN rates.
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Affiliation(s)
- Sachin Wani
- Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, Colorado.
| | - Dag Holmberg
- Department of Molecular Medicine and Surgery, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden
| | - Giola Santoni
- Department of Molecular Medicine and Surgery, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden
| | - Joonas H Kauppila
- Department of Molecular Medicine and Surgery, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden; Department of Surgery, Oulu University Hospital and University of Oulu, Oulu, Finland
| | - Martti Farkkila
- Clinic of Gastroenterology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
| | | | - Nicholas J Shaheen
- Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina
| | - Jesper Lagergren
- Department of Molecular Medicine and Surgery, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden; School of Cancer and Pharmaceutical Sciences, King's College London, London, United Kingdom
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Davis C, Fuller A, Katzka D, Wani S, Sawas T. High Proportions of Newly Detected Visible Lesions and Pathology Grade Change Among Patients with Barrett's Esophagus Referred to Expert Centers. Dig Dis Sci 2023; 68:3584-3595. [PMID: 37402985 DOI: 10.1007/s10620-023-07968-4] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/02/2023] [Accepted: 05/03/2023] [Indexed: 07/06/2023]
Abstract
BACKGROUND AND AIMS Endoscopic eradication therapy for Barrett's esophagus (BE)-related neoplasia is increasingly being performed at tertiary and community centers. While it has been suggested that these patients should be evaluated at expert centers, the impact of this practice has not been evaluated. We aimed to assess the impact of referral of BE-related neoplasia patients to expert centers by assessing the proportion of patients with change in pathological diagnosis and visible lesions detected. METHODS Multiple databases were searched until December 2021 for studies of patients with BE referred from the community to expert center. The proportions of pathology grade change and newly detected visible lesions at expert centers were pooled using a random-effects model. Subgroup analyses were performed based on baseline histology and other relevant factors. RESULTS Twelve studies were included (1630 patients). The pooled proportion of pathology grade change after expert pathologist review was 47% (95% CI 34-59%) overall and 46% (95% CI 31-62%) among patients with baseline low-grade dysplasia. When upper endoscopy was repeated at an expert center, the pooled proportion of pathology grade change was still high 47% (95% 26-69%) overall and 40% (95% CI 34-45%) among patients with baseline LGD. The pooled proportion of newly detected visible lesions was 45% (95% CI 28-63%) and among patients referred with LGD was 27% (95% CI 22-32%). CONCLUSION An alarmingly high proportion of newly detected visible lesions and pathology grade change were found when patients were referred to expert centers supporting the need for centralized care for BE-related neoplasia patients.
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Affiliation(s)
- Christian Davis
- Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA
| | - Andrew Fuller
- Department of Internal Medicine, University of Texas Southwestern, Dallas, TX, USA
| | - David Katzka
- Division of Gastroenterology and Hepatology, Columbia University, New York, NY, USA
| | - Sachin Wani
- Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA
| | - Tarek Sawas
- Division of Digestive and Liver Diseases, University of Texas Southwestern, 1801 Inwood Rd Ste 6-102, Dallas, TX, 75235, USA.
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Iyer PG, Chak A. Surveillance in Barrett's Esophagus: Challenges, Progress, and Possibilities. Gastroenterology 2023; 164:707-718. [PMID: 36746210 PMCID: PMC10079619 DOI: 10.1053/j.gastro.2023.01.031] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/07/2022] [Revised: 01/12/2023] [Accepted: 01/13/2023] [Indexed: 02/08/2023]
Abstract
Endoscopic surveillance of Barrett's esophagus, aiming to detect prevalent dysplasia and adenocarcinoma, followed by effective endoscopic treatment, is an integral part of the esophageal adenocarcinoma prevention paradigm. However, several limitations, such as the subtle appearance of dysplasia, sampling error (inherent in current surveillance protocols), and noncompliance with surveillance recommendations, lead to missed dysplasia and neoplasia, reducing the effectiveness of surveillance as currently practiced. Careful endoscopic assessment with high-resolution white-light endoscopy, dye-based or electronic chromoendoscopy, and comprehensive sampling of the BE mucosa, remains the cornerstone of endoscopic surveillance. Emerging innovations in this area span the gamut of more efficient sampling methods, advanced imaging tools, artificial intelligence, and molecular marker-powered approaches as adjuncts, to identify prevalent and predict incident dysplasia or adenocarcinoma. Development and implementation of validated quality indicators will allow additional advancement of this critical field. These approaches will hopefully enable efficient and effective cancer prevention and treatment.
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Affiliation(s)
- Prasad G Iyer
- Barrett's Esophagus Unit, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
| | - Amitabh Chak
- Division of Gastroenterology and Hepatology, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, Ohio
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Wide Variability in Dysplasia Detection Rate and Adherence to Seattle Protocol and Surveillance Recommendations in Barrett' Esophagus: A Population-Based Analysis using the GIQuIC National Quality Benchmarking Registry. Am J Gastroenterol 2022; 118:900-904. [PMID: 36623168 PMCID: PMC10159981 DOI: 10.14309/ajg.0000000000002102] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/12/2022] [Accepted: 11/02/2022] [Indexed: 01/11/2023]
Abstract
INTRODUCTION Variability in adherence rates to the Seattle protocol and to surveillance interval recommendations, established quality indicators (QIs) in Barrett's esophagus (BE), are unknown. METHODS We evaluated endoscopist and site-based adherence rates to these QIs from 1/2018-5/2021 using the GI Quality Improvement Consortium (GIQuIC) national registry with matched endoscopy and pathology data. RESULTS Across 153 practices with 572 endoscopists performing 20,155 endoscopies, adherence to Seattle protocol varied by endoscopists (median 93.8%, IQR 18.9%) and by site (median 90.0%, IQR 20.1%). Adherence to appropriate surveillance intervals for nondysplastic BE also varied by endoscopist (median 82.4%, IQR 36.3%) and site (median 77.2%, IQR 29.8%). Overall dysplasia detection rate was 3.1% and varied among endoscopists and sites. CONCLUSION These US population-based results can serve as a benchmark for quality initiatives and intervention trials aimed at improving outcomes for BE patients.
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Muthusamy VR, Wani S, Gyawali CP, Komanduri S. AGA Clinical Practice Update on New Technology and Innovation for Surveillance and Screening in Barrett's Esophagus: Expert Review. Clin Gastroenterol Hepatol 2022; 20:2696-2706.e1. [PMID: 35788412 PMCID: PMC10203866 DOI: 10.1016/j.cgh.2022.06.003] [Citation(s) in RCA: 56] [Impact Index Per Article: 18.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/28/2022] [Revised: 05/14/2022] [Accepted: 06/10/2022] [Indexed: 01/27/2023]
Abstract
DESCRIPTION The purpose of this best practice advice (BPA) article from the Clinical Practice Update Committee of the American Gastroenterological Association is to provide an update on advances and innovation regarding the screening and surveillance of Barrett's esophagus. METHODS The BPA statements presented here were developed from expert review of existing literature combined with discussion and expert opinion to provide practical advice. Formal rating of the quality of evidence or strength of BPAs was not the intent of this clinical practice update. This expert review was commissioned and approved by the AGA Institute Clinical Practice Updates Committee (CPUC) 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 CPUC and external peer review through standard procedures of Clinical Gastroenterology and Hepatology. BEST PRACTICE ADVICE 1: Screening with standard upper endoscopy may be considered in individuals with at least 3 established risk factors for Barrett's esophagus (BE) and esophageal adenocarcinoma, including individuals who are male, non-Hispanic white, age >50 years, have a history of smoking, chronic gastroesophageal reflux disease, obesity, or a family history of BE or esophageal adenocarcinoma. BEST PRACTICE ADVICE 2: Nonendoscopic cell-collection devices may be considered as an option to screen for BE. BEST PRACTICE ADVICE 3: Screening and surveillance endoscopic examination should be performed using high-definition white light endoscopy and virtual chromoendoscopy, with endoscopists spending adequate time inspecting the Barrett's segment. BEST PRACTICE ADVICE 4: Screening and surveillance exams should define the extent of BE using a standardized grading system documenting the circumferential and maximal extent of the columnar lined esophagus (Prague classification) with a clear description of landmarks and the location and characteristics of visible lesions (nodularity, ulceration), when present. BEST PRACTICE ADVICE 5: Advanced imaging technologies such as endomicroscopy may be used as adjunctive techniques to identify dysplasia. BEST PRACTICE ADVICE 6: Sampling during screening and surveillance exams should be performed using the Seattle biopsy protocol (4-quadrant biopsies every 1-2 cm and target biopsies from any visible lesion). BEST PRACTICE ADVICE 7: Wide-area transepithelial sampling may be used as an adjunctive technique to sample the suspected or established Barrett's segment (in addition to the Seattle biopsy protocol). BEST PRACTICE ADVICE 8: Patients with erosive esophagitis should be biopsied when concern of dysplasia or malignancy exists. A repeat endoscopy should be performed after 8 weeks of twice a day proton pump inhibitor therapy. BEST PRACTICE ADVICE 9: Tissue systems pathology-based prediction assay may be utilized for risk stratification of patients with nondysplastic BE. BEST PRACTICE ADVICE 10: Risk stratification models may be utilized to selectively identify individuals at risk for Barrett's associated neoplasia. BEST PRACTICE ADVICE 11: Given the significant interobserver variability among pathologists, the diagnosis of BE-related neoplasia should be confirmed by an expert pathology review. BEST PRACTICE ADVICE 12: Patients with BE-related neoplasia should be referred to endoscopists with expertise in advanced imaging, resection, and ablation. BEST PRACTICE ADVICE 13: All patients with BE should be placed on at least daily proton pump inhibitor therapy. BEST PRACTICE ADVICE 14: Patients with nondysplastic BE should undergo surveillance endoscopy in 3 to 5 years. BEST PRACTICE ADVICE 15: In patients undergoing surveillance after endoscopic eradication therapy, random biopsies should be taken of the esophagogastric junction, gastric cardia, and the distal 2 cm of the neosquamous epithelium as well as from all visible lesions, independent of the length of the original BE segment.
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Affiliation(s)
- V Raman Muthusamy
- Vatche and Tamar Manoukian Division of Digestive Diseases, University of California, Los Angeles, Los Angeles, California
| | - Sachin Wani
- Division of Gastroenterology and Hepatology, University of Colorado School of Medicine, Denver, Colorado
| | - C Prakash Gyawali
- Division of Gastroenterology, Washington University School of Medicine, St. Louis, Missouri
| | - Srinadh Komanduri
- Division of Gastroenterology and Hepatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
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Martinek J. Barrett's esophagus - screening or surveillance, and what about the quality of endoscopy? Endoscopy 2022; 54:890-891. [PMID: 35636452 DOI: 10.1055/a-1835-2252] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/10/2022]
Affiliation(s)
- Jan Martinek
- Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
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Alexandre L, Tsilegeridis-Legeris T, Lam S. Clinical and Endoscopic Characteristics Associated With Post-Endoscopy Upper Gastrointestinal Cancers: A Systematic Review and Meta-analysis. Gastroenterology 2022; 162:1123-1135. [PMID: 34958760 DOI: 10.1053/j.gastro.2021.12.270] [Citation(s) in RCA: 26] [Impact Index Per Article: 8.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/02/2021] [Revised: 11/27/2021] [Accepted: 12/22/2021] [Indexed: 12/26/2022]
Abstract
BACKGROUND & AIMS Ten percent of patients with an upper gastrointestinal cancer will have received an esophagogastroduodenoscopy (EGD) within 3 years before diagnosis, termed post-endoscopy upper gastrointestinal cancers (PEUGIC). We aimed to determine the characteristics of PEUGIC, and compare these with detected cancers. METHODS We searched MEDLINE and Embase from inception for studies comparing the characteristics of PEUGIC and detected upper gastrointestinal cancers, and reported findings at the initial "cancer-negative" endoscopy. We synthesized results using random effects meta-analysis. This review is registered on PROSPERO, CRD42019125780. RESULTS A total of 2696 citations were screened and 25 studies were included, comprising 81,184 UGI cancers, of which 7926 were considered PEUGIC. For PEUGIC assessed within 6 to 36 months of a "cancer-negative" EGD, the mean interval was approximately 17 months. Patients with PEUGIC were less likely to present with dysphagia (odds ratio [OR] 0.37) and weight loss (OR 0.58) and were more likely to present with gastroesophageal reflux (OR 2.64) than detected cancers. PEUGICs were more common in women in Western populations (OR 1.30). PEUGICs were typically smaller at diagnosis and associated with less advanced disease staging compared with detected cancers (OR 2.87 for stage 1 vs 2-4). Most EGDs (>75%) were abnormal preceding diagnosis of PEUGIC. CONCLUSIONS There is a substantial delay in the diagnosis of PEUGIC. They are less likely to present with alarm symptoms than detected cancers. PEUGICs are overall less advanced at diagnosis. Most patients with PEUGIC have abnormalities reported at the preceding "cancer-negative" EGD. The epidemiology of PEUGIC may inform preventive strategy.
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Affiliation(s)
- Leo Alexandre
- Norwich Medical School, University of East Anglia, Norwich, UK; Department of Gastroenterology, Norfolk & Norwich University Hospital NHS Foundation Trust, Norwich, UK.
| | | | - Stephen Lam
- Norwich Medical School, University of East Anglia, Norwich, UK; Department of General Surgery, Norfolk & Norwich University Hospital NHS Foundation Trust, Norwich, UK
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