Browsing by Author "Elmunzer, B. Joseph"
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Item Association Between Preadmission Acid Suppressive Medication Exposure and Severity of Illness in Patients Hospitalized With COVID-19(Elsevier, 2021) Elmunzer, B. Joseph; Wolf, Bethany J.; Scheiman, James M.; Tierney, William M.; Taylor, Jason R.; North American Alliance for the Study of Digestive Manifestations of COVID-19; Community and Global Health, Richard M. Fairbanks School of Public HealthItem Clinical Trials in Pancreatitis: Opportunities and Challenges in the Design and Conduct of Patient-Focused Clinical Trials in Recurrent Acute and Chronic Pancreatitis: Summary of a National Institute of Diabetes and Digestive and Kidney Diseases Workshop(Wolters Kluwer, 2022) Hart, Phil A.; Andersen, Dana K.; Lyons, Erica; Cote, Gregory A.; Cruz-Monserrate, Zobeida; Dworkin, Robert H.; Elmunzer, B. Joseph; Fogel, Evan L.; Forsmark, Christopher E.; Gilron, Ian; Golden, Megan; Gozu, Aysegul; McNair, Lindsay; Pandol, Stephen J.; Perito, Emily R.; Evans Phillips, Anna; Rabbitts, Jennifer A.; Whitcomb, David C.; Windsor, John A.; Yadav, Dhiraj; Palermo, Tonya M.; Medicine, School of MedicineRecurrent acute pancreatitis and chronic pancreatitis represent high morbidity diseases, which are frequently associated with chronic abdominal pain, pancreatic insufficiencies, and reduced quality of life. Currently, there are no therapies to reverse or delay disease progression, and clinical trials are needed to investigate potential interventions that would address this important gap. This conference report provides details regarding information shared during a National Institute of Diabetes and Digestive and Kidney Diseases-sponsored workshop on Clinical Trials in Pancreatitis that sought to clearly delineate the current gaps and opportunities related to the design and conduct of patient-focused trials in recurrent acute pancreatitis and chronic pancreatitis. Key stakeholders including representatives from patient advocacy organizations, physician investigators (including clinical trialists), the US Food and Drug Administration, and the National Institutes of Health convened to discuss challenges and opportunities with particular emphasis on lessons learned from trials in participants with other painful conditions, as well as the value of incorporating the patient perspective throughout all stages of trials.Item Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial(Elsevier, 2019-10) Pohl, Heiko; Grimm, Ian S.; Moyer, Matthew T.; Hasan, Muhammad K.; Pleskow, Douglas; Elmunzer, B. Joseph; Khashab, Mouen A.; Sanaei, Omid; Al-Kawas, Firas H.; Gordon, Stuart R.; Mathew, Abraham; Levenick, John M.; Aslanian, Harry R.; Antaki, Fadi; von Renteln, Daniel; Crockett, Seth D.; Rastogi, Amit; Gill, Jeffrey A.; Law, Ryan J.; Elias, Pooja A.; Pellise, Maria; Wallace, Michael B.; Mackenzie, Todd A.; Rex, Douglas K.; Medicine, School of MedicineBackground & aims: Bleeding is the most common severe complication after endoscopic mucosal resection of large colon polyps and is associated with significant morbidity and cost. We examined whether prophylactic closure of the mucosal defect with hemoclips after polyp resection reduces the risk of bleeding. Methods: We performed a multicenter, randomized trial of patients with a large nonpedunculated colon polyp (≥20 mm) at 18 medical centers in North America and Spain from April 2013 through October 2017. Patients were randomly assigned to groups that underwent endoscopic closure with a clip (clip group) or no closure (control group) and followed. The primary outcome, postprocedure bleeding, was defined as a severe bleeding event that required hospitalization, a blood transfusion, colonoscopy, surgery, or another invasive intervention within 30 days after completion of the colonoscopy. Subgroup analyses included postprocedure bleeding with polyp location, polyp size, or use of periprocedural antithrombotic medications. We also examined the risk of any serious adverse event. Results: A total of 919 patients were randomly assigned to groups and completed follow-up. Postprocedure bleeding occurred in 3.5% of patients in the clip group and 7.1% in the control group (absolute risk difference [ARD] 3.6%; 95% confidence interval [CI] 0.7%-6.5%). Among 615 patients (66.9%) with a proximal large polyp, the risk of bleeding in the clip group was 3.3% and in the control group was 9.6% (ARD 6.3%; 95% CI 2.5%-10.1%); among patients with a distal large polyp, the risks were 4.0% in the clip group and 1.4% in the control group (ARD -2.6%; 95% CI -6.3% to -1.1%). The effect of clip closure was independent of antithrombotic medications or polyp size. Serious adverse events occurred in 4.8% of patients in the clip group and 9.5% of patients in the control group (ARD 4.6%; 95% CI 1.3%-8.0%). Conclusions: In a randomized trial, we found that endoscopic clip closure of the mucosal defect following resection of large colon polyps reduces risk of postprocedure bleeding. The protective effect appeared to be restricted to large polyps located in the proximal colon.Item Current Knowledge and Research Priorities in the Digestive Manifestations of COVID-19(Elsevier, 2020) Aroniadis, Olga C.; DiMaio, Christopher J.; Dixon, Rebekah E.; Elmunzer, B. Joseph; Kolb, Jennifer M.; Mendelsohn, Robin; Ordiah, Collins O.; Rockey, Don C.; Singal, Amit G.; Spitzer, Rebecca L.; Tierney, William M.; Wani, Sachin; Yadav, Dhiraj; Global Health, School of Public HealthItem Development and initial validation of an instrument for video-based assessment of technical skill in ERCP(Elsevier, 2021) Elmunzer, B. Joseph; Walsh, Catharine M.; Guiton, Gretchen; Serrano, Jose; Chak, Amitabh; Edmundowicz, Steven; Kwon, Richard S.; Mullady, Daniel; Papachristou, Georgios I.; Elta, Grace; Baron, Todd H.; Yachimski, Patrick; Fogel, Evan L.; Draganov, Peter V.; Taylor, Jason R.; Scheiman, James; Singh, Vikesh K.; Varadarajulu, Shyam; Willingham, Field F.; Cote, Gregory A.; Cotton, Peter B.; Simon, Violette; Spitzer, Rebecca; Keswani, Rajesh; Wani, Sachin; SVI study group; U.S. Cooperative for Outcomes Research in Endoscopy; Medicine, School of MedicineBackground and aims: The accurate measurement of technical skill in ERCP is essential for endoscopic training, quality assurance, and coaching of this procedure. Hypothesizing that technical skill can be measured by analysis of ERCP videos, we aimed to develop and validate a video-based ERCP skill assessment tool. Methods: Based on review of procedural videos, the task of ERCP was deconstructed into its basic components by an expert panel that developed an initial version of the Bethesda ERCP Skill Assessment Tool (BESAT). Subsequently, 2 modified Delphi panels and 3 validation exercises were conducted with the goal of iteratively refining the tool. Fully crossed generalizability studies investigated the contributions of assessors, ERCP performance, and technical elements to reliability. Results: Twenty-nine technical elements were initially generated from task deconstruction. Ultimately, after iterative refinement, the tool comprised 6 technical elements and 11 subelements. The developmental process achieved consistent improvements in the performance characteristics of the tool with every iteration. For the most recent version of the tool, BESAT-v4, the generalizability coefficient (a reliability index) was .67. Most variance in BESAT scores (43.55%) was attributed to differences in endoscopists' skill, indicating that the tool can reliably differentiate between endoscopists based on video analysis. Conclusions: Video-based assessment of ERCP skill appears to be feasible with a novel instrument that demonstrates favorable validity evidence. Future steps include determining whether the tool can discriminate between endoscopists of varying experience levels and predict important outcomes in clinical practice.Item Digestive Manifestations in Patients Hospitalized With Coronavirus Disease 2019(Elsevier, 2020-10-01) Elmunzer, B. Joseph; Spitzer, Rebecca L.; Foster, Lydia D.; Merchant, Ambreen A.; Howard, Eric F.; Patel, Vaishali A.; West, Mary K.; Qayed, Emad; Nustas, Rosemary; Zakaria, Ali; Piper, Marc S.; Taylor, Jason R.; Jaza, Lujain; Forbes, Nauzer; Chau, Millie; Lara, Luis F.; Papachristou, Georgios I.; Volk, Michael L.; Hilson, Liam G.; Zhou, Selena; Kushnir, Vladimir M.; Lenyo, Alexandria M.; McLeod, Caroline G.; Amin, Sunil; Kuftinec, Gabriela N.; Yadav, Dhiraj; Fox, Charlie; Kolb, Jennifer M.; Pawa, Swati; Pawa, Rishi; Canakis, Andrew; Huang, Christopher; Jamil, Laith H.; Aneese, Andrew M.; Glamour, Benita K.; Smith, Zachary L.; Hanley, Katherine A.; Wood, Jordan; Patel, Harsh K.; Shah, Janak N.; Agarunov, Emil; Sethi, Amrita; Fogel, Evan L.; McNulty, Gail; Haseeb, Abdul; Trieu, Judy A.; Dixon, Rebekah E.; Yang, Jeong Yun; Mendelsohn, Robin B.; Calo, Delia; Aroniadis, Olga C.; LaComb, Joseph F.; Scheiman, James M.; Sauer, Bryan G.; Dang, Duyen T.; Piraka, Cyrus R.; Shah, Eric D.; Pohl, Heiko; Tierney, William M.; Mitchell, Stephanie; Condon, Ashwinee; Lenhart, Adrienne; Dua, Kulwinder S.; Kanagala, Vikram S.; Kamal, Ayesha; Singh, Vikesh K.; Pinto-Sanchez, Maria Ines; Hutchinson, Joy M.; Kwon, Richard S.; Korsnes, Sheryl J.; Singh, Harminder; Solati, Zahra; Willingham, Field F.; Yachimski, Patrick S.; Conwell, Darwin L.; Mosier, Evan; Azab, Mohamed; Patel, Anish; Buxbaum, James; Wani, Sachin; Chak, Amitabh; Hosmer, Amy E.; Keswani, Rajesh N.; DiMaio, Christopher J.; Bronze, Michael S.; Muthusamy, Raman; Canto, Marcia I.; Gjeorgjievski, V. Mihajlo; Imam, Zaid; Odish, Fadi; Edhi, Ahmed I.; Orosey, Molly; Tiwari, Abhinav; Patwardhan, Soumil; Brown, Nicholas G.; Patel, Anish A.; Ordiah, Collins O.; Sloan, Ian P.; Cruz, Lilian; Koza, Casey L.; Okafor, Uchechi; Hollander, Thomas; Furey, Nancy; Reykhart, Olga; Zbib, Natalia H.; Damianos, John A.; Esteban, James; Hajidiacos, Nick; Saul, Melissa; Mays, Melanie; Anderson, Gulsum; Wood, Kelley; Mathews, Laura; Diakova, Galina; Caisse, Molly; Wakefield, Lauren; Nitchie, Haley; Waljee, Akbar K.; Tang, Weijing; Zhang, Yueyang; Zhu, Ji; Deshpande, Amar R.; Rockey, Don C.; Alford, Teldon B.; Durkalski, Valerie; Medicine, School of MedicineBackground & Aims The prevalence and significance of digestive manifestations in coronavirus disease 2019 (COVID-19) remain uncertain. We aimed to assess the prevalence, spectrum, severity, and significance of digestive manifestations in patients hospitalized with COVID-19. Methods Consecutive patients hospitalized with COVID-19 were identified across a geographically diverse alliance of medical centers in North America. Data pertaining to baseline characteristics, symptomatology, laboratory assessment, imaging, and endoscopic findings from the time of symptom onset until discharge or death were abstracted manually from electronic health records to characterize the prevalence, spectrum, and severity of digestive manifestations. Regression analyses were performed to evaluate the association between digestive manifestations and severe outcomes related to COVID-19. Results A total of 1992 patients across 36 centers met eligibility criteria and were included. Overall, 53% of patients experienced at least 1 gastrointestinal symptom at any time during their illness, most commonly diarrhea (34%), nausea (27%), vomiting (16%), and abdominal pain (11%). In 74% of cases, gastrointestinal symptoms were judged to be mild. In total, 35% of patients developed an abnormal alanine aminotransferase or total bilirubin level; these were increased to less than 5 times the upper limit of normal in 77% of cases. After adjusting for potential confounders, the presence of gastrointestinal symptoms at any time (odds ratio, 0.93; 95% CI, 0.76–1.15) or liver test abnormalities on admission (odds ratio, 1.31; 95% CI, 0.80–2.12) were not associated independently with mechanical ventilation or death. Conclusions Among patients hospitalized with COVID-19, gastrointestinal symptoms and liver test abnormalities were common, but the majority were mild and their presence was not associated with a more severe clinical course.Item Digestive Manifestations in Patients Hospitalized With Coronavirus Disease 2019(Elsevier, 2021-07) Elmunzer, B. Joseph; Spitzer, Rebecca L.; Foster, Lydia D.; Merchant, Ambreen A.; Howard, Eric F.; Patel, Vaishali A.; West, Mary K.; Qayed, Emad; Nustas, Rosemary; Zakaria, Ali; Piper, Marc S.; Taylor, Jason R.; Jaza, Lujain; Forbes, Nauzer; Chau, Millie; Lara, Luis F.; Papachristou, Georgios I.; Volk, Michael L.; Hilson, Liam G.; Zhou, Selena; Kushnir, Vladimir M.; Lenyo, Alexandria M.; McLeod, Caroline G.; Amin, Sunil; Kuftinec, Gabriela N.; Yadav, Dhiraj; Fox, Charlie; Kolb, Jennifer M.; Pawa, Swati; Pawa, Rishi; Canakis, Andrew; Huang, Christopher; Jamil, Laith H.; Aneese, Andrew M.; Glamour, Benita K.; Smith, Zachary L.; Hanley, Katherine A.; Wood, Jordan; Patel, Harsh K.; Shah, Janak N.; Agarunov, Emil; Sethi, Amrita; Fogel, Evan L.; McNulty, Gail; Haseeb, Abdul; Trieu, Judy A.; Dixon, Rebekah E.; Yang, Jeong Yun; Mendelsohn, Robin B.; Calo, Delia; Aroniadis, Olga C.; LaComb, Joseph F.; Scheiman, James M.; Sauer, Bryan G.; Dang, Duyen T.; Piraka, Cyrus R.; Shah, Eric D.; Pohl, Heiko; Tierney, William M.; Mitchell, Stephanie; Condon, Ashwinee; Lenhart, Adrienne; Dua, Kulwinder S.; Kanagala, Vikram S.; Kamal, Ayesha; Singh, Vikesh K.; Pinto-Sanchez, Maria Ines; Hutchinson, Joy M.; Kwon, Richard S.; Korsnes, Sheryl J.; Singh, Harminder; Solati, Zahra; Willingham, Field F.; Yachimski, Patrick S.; Conwell, Darwin L.; Mosier, Evan; Azab, Mohamed; Patel, Anish; Buxbaum, James; Wani, Sachin; Chak, Amitabh; Hosmer, Amy E.; Keswani, Rajesh N.; DiMaio, Christopher J.; Bronze, Michael S.; Muthusamy, Raman; Canto, Marcia I.; Gjeorgjievski, V. Mihajlo; Imam, Zaid; Odish, Fadi; Edhi, Ahmed I.; Orosey, Molly; Tiwari, Abhinav; Patwardhan, Soumil; Brown, Nicholas G.; Patel, Anish A.; Ordiah, Collins O.; Sloan, Ian P.; Cruz, Lilian; Koza, Casey L.; Okafor, Uchechi; Hollander, Thomas; Furey, Nancy; Reykhart, Olga; Zbib, Natalia H.; Damianos, John A.; Esteban, James; Hajidiacos, Nick; Saul, Melissa; Mays, Melanie; Anderson, Gulsum; Wood, Kelley; Mathews, Laura; Diakova, Galina; Caisse, Molly; Wakefield, Lauren; Nitchie, Haley; Waljee, Akbar K.; Tang, Weijing; Zhang, Yueyang; Zhu, Ji; Deshpande, Amar R.; Rockey, Don C.; Alford, Teldon B.; Durkalski, Valerie; North American Alliance for the Study of Digestive Manifestations of COVID-19; Medicine, School of MedicineBACKGROUND & AIMS: The prevalence and significance of digestive manifestations in coronavirus disease 2019 (COVID-19) remain uncertain. We aimed to assess the prevalence, spectrum, severity, and significance of digestive manifestations in patients hospitalized with COVID-19. METHODS: Consecutive patients hospitalized with COVID-19 were identified across a geographically diverse alliance of medical centers in North America. Data pertaining to baseline characteristics, symptomatology, laboratory assessment, imaging, and endoscopic findings from the time of symptom onset until discharge or death were abstracted manually from electronic health records to characterize the prevalence, spectrum, and severity of digestive manifestations. Regression analyses were performed to evaluate the association between digestive manifestations and severe outcomes related to COVID-19. RESULTS: A total of 1992 patients across 36 centers met eligibility criteria and were included. Overall, 53% of patients experienced at least 1 gastrointestinal symptom at any time during their illness, most commonly diarrhea (34%), nausea (27%), vomiting (16%), and abdominal pain (11%). In 74% of cases, gastrointestinal symptoms were judged to be mild. In total, 35% of patients developed an abnormal alanine aminotransferase or total bilirubin level; these were increased to less than 5 times the upper limit of normal in 77% of cases. After adjusting for potential confounders, the presence of gastrointestinal symptoms at any time (odds ratio, 0.93; 95% CI, 0.76-1.15) or liver test abnormalities on admission (odds ratio, 1.31; 95% CI, 0.80-2.12) were not associated independently with mechanical ventilation or death. CONCLUSIONS: Among patients hospitalized with COVID-19, gastrointestinal symptoms and liver test abnormalities were common, but the majority were mild and their presence was not associated with a more severe clinical course.Item Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution A Randomized Clinical Trial(JAMA, 2016-03) Coté, Gregory A.; Slivka, Adam; Tarnasky, Paul; Mullady, Daniel K.; Elmunzer, B. Joseph; Elta, Grace; Fogel, Evan; Lehman, Glen; McHenry, Lee; Romagnuolo, Joseph; Menon, Shyam; Siddiqui, Uzma D.; Watkins, James; Lynch, Sheryl; Denski, Cheryl; Xu, Huiping; Sherman, Stuart; Department of Biostatistics, Richard M. Fairbanks School of Public HealthImportance Endoscopic placement of multiple plastic stents in parallel is the first-line treatment for most benign biliary strictures; it is possible that fully covered, self-expandable metallic stents (cSEMS) may require fewer endoscopic retrograde cholangiopancreatography procedures (ERCPs) to achieve resolution. Objective To assess whether use of cSEMS is noninferior to plastic stents with respect to stricture resolution. Design, Setting, and Participants Multicenter (8 endoscopic referral centers), open-label, parallel, randomized clinical trial involving patients with treatment-naive, benign biliary strictures (N = 112) due to orthotopic liver transplant (n = 73), chronic pancreatitis (n = 35), or postoperative injury (n = 4), who were enrolled between April 2011 and September 2014 (with follow-up ending October 2015). Patients with a bile duct diameter less than 6 mm and those with an intact gallbladder in whom the cystic duct would be overlapped by a cSEMS were excluded. Interventions Patients (N = 112) were randomized to receive multiple plastic stents or a single cSEMS, stratified by stricture etiology and with endoscopic reassessment for resolution every 3 months (plastic stents) or every 6 months (cSEMS). Patients were followed up for 12 months after stricture resolution to assess for recurrence. Main Outcomes and Measures Primary outcome was stricture resolution after no more than 12 months of endoscopic therapy. The sample size was estimated based on the noninferiority of cSEMS to plastic stents, with a noninferiority margin of −15%. Results There were 55 patients in the plastic stent group (mean [SD] age, 57 [11] years; 17 women [31%]) and 57 patients in the cSEMS group (mean [SD] age, 55 [10] years; 19 women [33%]). Compared with plastic stents (41/48, 85.4%), the cSEMS resolution rate was 50 of 54 patients (92.6%), with a rate difference of 7.2% (1-sided 95% CI, −3.0% to ∞; P < .001). Given the prespecified noninferiority margin of −15%, the null hypothesis that cSEMS is less effective than plastic stents was rejected. The mean number of ERCPs to achieve resolution was lower for cSEMS (2.14) vs plastic (3.24; mean difference, 1.10; 95% CI, 0.74 to 1.46; P < .001). Conclusions and Relevance Among patients with benign biliary strictures and a bile duct diameter 6 mm or more in whom the covered metallic stent would not overlap the cystic duct, cSEMS were not inferior to multiple plastic stents after 12 months in achieving stricture resolution. Metallic stents should be considered an appropriate option in patients such as these.Item Effects of Blended (Yellow) vs Forced Coagulation (Blue) Currents on Adverse Events, Complete Resection, or Polyp Recurrence After Polypectomy in a Large Randomized Trial(Elsevier, 2020-07) Pohl, Heiko; Grimm, Ian S.; Moyer, Matthew T.; Hasan, Muhammad K.; Pleskow, Douglas; Elmunzer, B. Joseph; Khashab, Mouen A.; Sanaei, Omid; Al-Kawas, Firas H.; Gordon, Stuart R.; Mathew, Abraham; Levenick, John M.; Aslanian, Harry R.; Antaki, Fadi; von Renteln, Daniel; Crockett, Seth D.; Rastogi, Amit; Gill, Jeffrey A.; Law, Ryan J.; Elias, Pooja A.; Pellise, Maria; Mackenzie, Todd A.; Rex, Douglas K.; Medicine, School of MedicineBackground & aims: There is debate over the type of electrosurgical setting that should be used for polyp resection. Some endoscopists use a type of blended current (yellow), whereas others prefer coagulation (blue). We performed a single-blinded, randomized trial to determine whether type of electrosurgical setting affects risk of adverse events or recurrence. Methods: Patients undergoing endoscopic mucosal resection of nonpedunculated colorectal polyps 20 mm or larger (n = 928) were randomly assigned, in a 2 × 2 design, to groups that received clip closure or no clip closure of the resection defect (primary intervention) and then to either a blended current (Endocut Q) or coagulation current (forced coagulation) (Erbe Inc) (secondary intervention and focus of the study). The study was performed at multiple centers, from April 2013 through October 2017. Patients were evaluated 30 days after the procedure (n = 919), and 675 patients underwent a surveillance colonoscopy at a median of 6 months after the procedure. The primary outcome was any severe adverse event in a per patient analysis. Secondary outcomes were complete resection and recurrence at first surveillance colonoscopy in a per polyp analysis. Results: Serious adverse events occurred in 7.2% of patients in the Endocut group and 7.9% of patients in the forced coagulation group, with no significant differences in the occurrence of types of events. There were no significant differences between groups in proportions of polyps that were completely removed (96% in the Endocut group vs 95% in the forced coagulation group) or the proportion of polyps found to have recurred at surveillance colonoscopy (17% and 17%, respectively). Procedural characteristics were comparable, except that 17% of patients in the Endocut group had immediate bleeding that required an intervention, compared with 11% in the forced coagulation group (P = .006). Conclusions: In a randomized trial to compare 2 commonly used electrosurgical settings for the resection of large colorectal polyps (Endocut vs forced coagulation), we found no difference in risk of serious adverse events, complete resection rate, or polyp recurrence. Electrosurgical settings can therefore be selected based on endoscopist expertise and preference.Item Outcomes of submucosal (T1b) esophageal adenocarcinomas removed by endoscopic mucosal resection(Baishideng Publishing Group, 2016-12-16) Ballard, Darren D.; Choksi, Neel; Lin, Jingmei; Choi, Eun-Young; Elmunzer, B. Joseph; Appelman, Henry; Rex, Douglas K.; Fatima, Hala; Kessler, William; DeWitt, John M.; Department of Pathology and Laboratory Medicine, IU School of MedicineAIM: To investigate the outcomes and recurrences of pT1b esophageal adenocarcinoma (EAC) following endoscopic mucosal resection (EMR) and associated treatments. METHODS: Patients undergoing EMR with pathologically confirmed T1b EAC at two academic referral centers were retrospectively identified. Patients were divided into 4 groups based on treatment following EMR: Endoscopic therapy alone (group A), endoscopic therapy with either chemotherapy, radiation or both (group B), surgical resection (group C) or no further treatment/lost to follow-up (< 12 mo) (group D). Pathology specimens were reviewed by a central pathologist. Follow-up data was obtained from the academic centers, primary care physicians and/or referring physicians. Univariate analysis was performed to identify factors predicting recurrence of EAC. RESULTS: Fifty-three patients with T1b EAC underwent EMR, of which 32 (60%) had adequate follow-up ≥ 12 mo (median 34 mo, range 12-103). There were 16 patients in group A, 9 in group B, 7 in group C and 21 in group D. Median follow-up in groups A to C was 34 mo (range 12-103). Recurrent EAC developed overall in 9 patients (28%) including 6 (38%) in group A (median: 21 mo, range: 6-73), 1 (11%) in group B (median: 30 mo, range: 30-30) and 2 (29%) in group C (median 21 mo, range: 7-35. Six of 9 recurrences were local; of the 6 recurrences, 5 were treated with endoscopy alone. No predictors of recurrence of EAC were identified. CONCLUSION: Endoscopic therapy of T1b EAC may be a reasonable strategy for a subset of patients including those either refusing or medically unfit for esophagectomy.