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Background and Aims: Endoscopic band ligation (EBL) without resection combined with single-incision needle-knife (SINK) biopsy sampling may have a positive impact on small GI subepithelial tumor (SET) management, but the method needs to be tested. The aim was to evaluate the feasibility of this strategy in small-sized SETs., Methods: This prospective multicenter observational cohort study in 7 centers included patients with SETs ≤15 mm (confirmed by EUS) between March 2017 and March 2020. The primary outcome was clinical success at 4 weeks, defined as complete SET disappearance on EUS. Secondary outcomes were long-term (1-year) clinical success, technical difficulty level, clinical impact, yield pathology, and safety., Results: Of 273 patients screened, 122 (62.3% women; mean age, 60.9 ± 13.2 years) were included with SETs (mean size, 9 ± 2.8 mm; gastric location, 77%; superficial layer dependence, 63%). The primary endpoint was achieved in 73.6% of patients (95% confidence interval [CI], 64.8-81.2). At the 1-year follow-up, the success rate was 68.4% (95% CI, 59.1-76.8). A favorable clinical impact was observed in 97 cases (79.5%; 95% CI, 71.3-86.3). Pathology diagnosis was known in 70%. Potentially malignant lesions were present in 24.7%. The related adverse events rate was 4.1% (95% CI, 1.3-9.3; all mild: 2 bleeding, 2 abdominal pain). On multivariable analysis, the ≤10-mm SET group was associated with a greater success rate (1 year, 87%; relative risk, 5.07; 95% CI, 2.63-9.8) and clinical impact rate (92.7%; relative risk, 6.15; 95% CI, 2.72-13.93)., Conclusions: EBL plus SINK biopsy sampling seems to be feasible and safe, and it may offer a favorable clinical impact in small-sized SETs. In particular, SETs ≤10 mm are the best candidates. (Clinical trial registration number: NCT03247231.)., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Traditionally, palliative treatment of malignant gastric outlet obstruction (GOO) has been surgical, but surgical treatment carries significant morbidity and mortality rates. Endoscopic placement of a duodenal self-expandable metal stent (D-SEMS) has been proven to be successful for this indication in the short term. However, D-SEMSs are likely to malfunction over time. EUS-guided gastroenterostomy (EUS-GE) may help overcome these limitations. We aimed to evaluate stent failure-free survival at 3 months., Methods: A nationwide multicenter, observational study of D-SEMS and EUS-GE procedures for patients with malignant GOO was conducted at 7 academic centers from January 2015 to June 2020. Stent failure-free survival at 1, 3, and 6 months; technical and clinical success; adverse events (AEs); and patient survival were evaluated in both groups and compared., Results: Ninety-seven patients were included in the D-SEMS group and 79 in the EUS-GE group. Pancreatic cancer was the main underlying malignancy in 53.4%. No statistically significant differences regarding technical (92.8% vs 93.7%) or clinical success (83.5% vs 92.4%) were found. AE rates did not differ between groups (10.3% vs 10.1%), although 2 events in the EUS-GE group required surgical management. Patients in the EUS-GE group had improved stent patency when compared with those patients in the D-SEMS group at 3 months (92.23% vs 80.6%; adjusted hazard ratio, .37; P = .033)., Conclusions: EUS-GE seems to have improved patency outcomes when compared with D-SEMS placement for palliative treatment of malignant GOO. Prospective trials are needed to fully compare their efficacy and AE profile., (Published by Elsevier Inc.)

Background and Aims: The risk of bleeding and thromboembolic events in patients undergoing peroral endoscopic myotomy (POEM) who are receiving antithrombotic therapy is unknown. Our primary aim was to assess the safety of POEM in this patient subset. Secondary outcomes were rates of clinical success, GERD, and procedure-related outcomes., Methods: This was an international, 1:1, case-control study performed at 10 centers using prospectively maintained databases. All consecutive patients who underwent POEM before November 2019 were considered for inclusion. Cases were patients on antiplatelet and/or anticoagulant therapy. Controls not receiving antithrombotics were matched for age and esophageal motility disorder. Primary outcomes were major bleeding and thromboembolic events on postprocedural day 30., Results: Of 2895 patients who underwent POEM, 126 cases (103 on antiplatelets, 35 anticoagulants, 12 both) and 126 controls were enrolled. The rate of major bleeding was higher for the antithrombotics users (5.6% vs 0.8%, P = .03). Anticoagulants and clopidogrel were temporarily interrupted in all cases. Aspirin was continued in 40.5% of users without increasing the bleeding risk. One thromboembolic event occurred in each group (0.79%; P = 1.00). No POEM-related deaths were noted. Rates of clinical success (91.7% vs 96% in controls, P = .20), postprocedural GERD, and technical-related outcomes were similar in both groups. Antithrombotic management was heterogeneous, and guidelines were not adhered to in 23.8% of cases., Conclusions: POEM is safe and effective in patients receiving antithrombotic therapy although it is associated with a greater risk of major bleeding., (Copyright © 2021 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: The Endoscopic Resection Group of the Spanish Society of Endoscopy (GSEED-RE) model and the Australian Colonic Endoscopic Resection (ACER) model were proposed to predict delayed bleeding (DB) after EMR of large superficial colorectal lesions, but neither has been validated. We validated and updated these models., Methods: A multicenter cohort study was performed in patients with nonpedunculated lesions ≥20 mm removed by EMR. We assessed the discrimination and calibration of the GSEED-RE and ACER models. Difficulty performing EMR was subjectively categorized as low, medium, or high. We created a new model, including factors associated with DB in 3 cohort studies., Results: DB occurred in 45 of 1034 EMRs (4.5%); it was associated with proximal location (odds ratio [OR], 2.84; 95% confidence interval [CI], 1.31-6.16), antiplatelet agents (OR, 2.51; 95% CI, .99-6.34) or anticoagulants (OR, 4.54; 95% CI, 2.14-9.63), difficulty of EMR (OR, 3.23; 95% CI, 1.41-7.40), and comorbidity (OR, 2.11; 95% CI, .99-4.47). The GSEED-RE and ACER models did not accurately predict DB. Re-estimation and recalibration yielded acceptable results (GSEED-RE area under the curve [AUC], .64 [95% CI, .54-.74]; ACER AUC, .65 [95% CI, .57-.73]). We used lesion size, proximal location, comorbidity, and antiplatelet or anticoagulant therapy to generate a new model, the GSEED-RE2, which achieved higher AUC values (.69-.73; 95% CI, .59-.80) and exhibited lower susceptibility to changes among datasets., Conclusions: The updated GSEED-RE and ACER models achieved acceptable prediction levels of DB. The GSEED-RE2 model may achieve better prediction results and could be used to guide the management of patients after validation by other external groups. (Clinical trial registration number: NCT03050333.)., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: Endoscopic therapy is the preferred approach for the management of Barrett's esophagus (BE) patients with high-grade dysplasia (HGD) and intramucosal carcinoma (IMC). Little is known about outcome differences in patients with HGD versus IMC., Objective: To determine and compare the rate of recurrent dysplasia or neoplasia in patients with HGD or IMC undergoing endoscopic therapy., Design: Retrospective cohort study., Patients: A total of 246 BE patients with either HGD or IMC referred for endoscopic therapy., Intervention: Patients underwent EMR and/or ablation therapy with the goal of complete eradication of all dysplasia/neoplasia and intestinal metaplasia (CE-IM). Patients were assigned to either the HGD or IMC group based on highest pathology grade at the start of therapy., Main Outcome Measurements: Complete eradication and recurrence of IM and/or HGD/neoplasia were assessed among patients with HGD versus IMC. Only patients with CE-IM (documented eradication of all dysplasia/neoplasia and IM on a single endoscopy) were included for analysis of recurrence rates and risk factors., Results: CE-IM was achieved in 113 of 135 patients (83.7%) with HGD and in 84 of 111 patients (75.7%) with IMC (P = .16). Overall recurrence rates of dysplasia or neoplasia after CE-IM were similar in both groups (HGD, 8.0% vs IMC, 9.5%; P = .44; relative risk, 1.2; 95% confidence interval, 0.5-3.0) and remained similar in patients with 5 years of surveillance after CE-IM (HGD, 13.5% vs IMC, 11.4%; P = .53; relative risk, 0.85; 95% confidence interval, 0.3-2.7)., Limitations: Retrospective, observational study and evolution of endoscopic modalities and experience., Conclusion: Endoluminal therapy can successfully achieve eradication of IM and dysplasia or neoplasia in BE patients with HGD and IMC at comparable rates. There were no differences in the rates of recurrent HGD/IMC in the 2 groups., (Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: Early cancer (high-grade dysplasia [HGD] and intramucosal carcinoma [ImCa]) associated with Barrett's esophagus (BE) may have a circumferential spatial predilection., Objective: To describe the esophageal circumferential location of early cancer in BE., Design and Setting: Retrospective study, single tertiary referral center., Patients and Intervention: One hundred nineteen patients were referred for endoscopic eradication therapy for early cancer associated with BE. Endoscopic images and reports and pathology were reviewed., Main Outcome Measurements: Circumferential location designation of early cancer in BE by using a clock-face orientation., Results: One hundred nineteen of 131 patients referred for endoscopic eradication therapy had a location designation for their advanced histology (91.9%). There were a total of 57 patients (47.9%) with HGD and 62 patients (52.1%) with ImCa. There was a significantly higher rate of early cancer (HGD or ImCa) in the right hemisphere (12 to 6 o'clock location) compared with the left hemisphere (84.9% vs 15.1%, P < .0001). The highest percentage of early cancer was found in the 12 to 3 o'clock quadrant (64.7%); 71.9% of HGD and 58.1% of ImCa lesions were located in the 12 to 3 o'clock quadrant., Limitations: Retrospective design, single center., Conclusions: Early cancer associated with BE is far more commonly found in the right hemisphere of the esophagus (12 to 6 o'clock) with the highest rate in the 12 to 3 o'clock quadrant. These findings support enhanced scrutiny of the right hemisphere of the esophagus during surveillance and endoscopic treatment of patients with BE., (Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Endoluminal therapy is an option for selected patients with Barrett's esophagus and high-grade dysplasia or early cancer., Objective: To assess long-term outcomes of patients treated with endoluminal therapy with the goal of complete eradication of all dysplasia and intestinal metaplasia., Design: Retrospective cohort study., Patients: Selected patients referred with dysplastic Barrett's esophagus., Intervention: Endoluminal therapy combining resection and photodynamic therapy, radiofrequency ablation, and/or argon plasma coagulation treatment was individualized based on patient and lesion characteristics, technique evolution, and interval response., Main Outcome Measurements: We assessed complete eradication of dysplasia, all intestinal metaplasia, and recurrences., Results: A total of 166 patients were treated and had at least 1 year of follow-up. Complete elimination of neoplasia was achieved in 157 patients (95%) and complete elimination of intestinal metaplasia in 137 patients (83%). After therapy, patients were followed for 33 (range 18-58) months. Among patients who achieved complete elimination of intestinal metaplasia, subsequent recurrent intestinal metaplasia was detected in 48 (35%) and dysplasia in 12 (9%). Among those who achieved only complete elimination of dysplasia, recurrent dysplasia was detected in 6 of 19 patients (32%). Multifocal dysplasia and patient's age were dysplasia and/or carcinoma recurrence risk factors in the multivariable and univariable analyses. Complete elimination of intestinal metaplasia was a protective factor in the univariable analysis. Retreatment achieved remission in 90% of cases. Forty-two patients (23.9%) had complications, including 21 with stricture (11.9%) and 1 treatment-related death., Limitations: Retrospective study and evolution of endoscopic modalities., Conclusion: Multiple-mode endoluminal therapy for Barrett's esophagus with high-grade dysplasia or early cancer with intention to complete eradication of all intestinal metaplasia was successful, with low observed recurrence of dysplasia or cancer. However, recurrence of intestinal metaplasia occurs in one-third of cases and supports continued endoscopic surveillance even after complete eradication., (Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Endoscopic insufflation has been associated with marked increase in intra-abdominal pressure (IAP) and hemodynamic and respiratory changes during transgastric surgery., Objective: To investigate the hemodynamic and respiratory effects during intraperitoneal cavity exploration through 3 different natural orifice transluminal endoscopic surgery (NOTES) access locations compared with laparoscopy., Design and Setting: Survival experiments using 40 female pigs randomized to transgastric, transcolonic, transvaginal, and laparoscopic peritoneoscopy., Interventions: On-demand endoscopic insufflation of CO(2) with feedback pressure regulation was used in NOTES with a maximum pressure of 14 mm Hg. In the laparoscopy group, the IAP was maintained at 14 mm Hg. NOTES procedures were performed by an endoscopist (with the assistance of a gynecologist in the transvaginal group and a second endoscopist in the transgastric and transrectal groups) and laparoscopy by 2 surgeons., Main Outcome Measurements: Invasive hemodynamic and respiratory data. Blood samples were drawn for gas analyses., Results: All experiments except one in the transrectal group were completed. The IAP was significantly lower in all NOTES groups compared with the laparoscopy group. A significant increase in mean systemic arterial blood pressure was observed in the laparoscopy group at 15 and 30 minutes of intraperitoneal cavity exploration, but it remained unchanged during all NOTES procedures. An increase in airway pressures was observed at 15 and 30 minutes of peritoneoscopy in the animals undergoing laparoscopy, whereas those parameters remained unchanged in the NOTES groups. The laparoscopy group showed a significant impairment in pulmonary gas exchange (decrease in Pao(2), increase in Paco(2), and decrease in arterial pH) after 30 minutes of peritoneoscopy, whereas only a slight increase in Paco(2) was observed in the transrectal and transvaginal groups., Limitations: Healthy animal model., Conclusion: On-demand endoscopic insufflation of CO(2) with feedback pressure regulation can minimize the risk of hemodynamic and respiratory compromise caused by acute changes in IAP., (Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Flat and sessile lesions are being identified more frequently because of increased awareness, improved endoscopic skills, and enhanced imaging. The defiant polyp (DP) is a lesion identified at colonoscopy that defies resection by the standard snare polypectomy technique. Increasingly, the DP undergoes photodocumentation and tissue sampling, and the patient is referred for an attempt at curative colonoscopic resection., Objective: To evaluate the current nature of the DPs and outcomes of their endoscopic resection., Design: Retrospective study., Setting: Tertiary referral center., Patients and Interventions: Patients with colorectal polyps not amenable to standard snare polypectomy were referred to a single endoscopist at a tertiary center for an attempt at curative endoscopic resection. The indication DP was applied prospectively, as defined previously, beginning in June 2007. An electronic endoscopy report database was searched for this indication from June 2007 to October 2009 for a single endoscopist at an endoscopy referral center. Data pertaining to patient age and sex, polyp site and histopathology, resection technique, use of adjunctive ablation, adverse events, and residual/recurrent neoplasia at follow-up were culled. Submucosal injection of varying quantities of normal saline solution tinted with methylene blue dye was used for endoscopic resection. Standard and mini-snares were used with pure coagulation current., Main Outcome Measurements: Complete resection, complications, recurrence., Results: This study included 274 patients (50.4% women, age 65 [standard deviation 12] years) with a total of 315 DPs who were referred for attempted endoscopic resection. The majority of DPs were located in the right side of the colon (226; 72%). The mean size was estimated at 23 mm (range 8-100 mm; standard deviation 13). In 29 DPs (10%), surgery was required because endoscopic resection was deemed unsuitable because of the unfavorable appearance (n = 3), the location (n = 9), or the inability to lift (n = 10) or because of submucosal invasion on post-EMR histopathology (n = 7). Complete endoscopic eradication (R0) was achieved in a single session in 286 DPs (91%). En bloc resection was performed in 153 polyps (53.5%) and piecemeal resection in 132 (46%). Histopathology revealed 178 tubular adenomas (56.5%), 62 serrated adenomas (20%), 27 tubulovillous adenomas (9%), 10 hyperplastic polyps (3%), and 14 adenocarcinomas (4.5%). Adjunctive ablation of focal residual neoplastic tissue was applied in 69 DPs (24%) to achieve R0. Procedure-related adverse events were recorded in 29 of 249 patients (11.6%). Acute bleeding occurred in 9 patients (1 required hospitalization and repeat endoscopy). There was 1 microperforation managed with clip closure and antibiotics. Delayed bleeding (1-6 days post-procedure) was observed in 18 patients (7.2%), of whom 8 required hospitalization and 4 colonoscopy for hemostasis. Among the patients who underwent follow-up surveillance colonoscopy (135 of 258 patients), residual/recurrent neoplastic tissue at the site of the previous EMR was identified in 36 (27%). Residual/recurrent neoplasia was successfully eradicated with further endoscopic resection or ablation., Limitations: A retrospective design., Conclusions: DPs consist predominantly of sessile and flat adenomas including serrated adenomas. Most DPs can be successfully eradicated at dedicated therapeutic colonoscopy by using adjunctive resection and ablation techniques. The R0 rate is high and the adverse event rate is low. A relatively high rate of local residual/recurrent neoplasia at the resection site underscores the importance of follow-up colonoscopy., (Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Pancreatic cystic lesions present a challenge for patients and physicians alike. Morphology alone is inaccurate in discriminating lesion pathology, and use of EUS-guided FNA (EUS-FNA) improves accuracy. Current American Society for Gastrointestinal Endoscopy guidelines recommend prophylactic antibiotics during FNA of cystic lesions to minimize infection risk. However, evidence pertaining to infection risk has been conflicting. The use of prophylactic antibiotics might not be free of other adverse events and might not prevent infection., Objective: To assess the impact of antimicrobial therapy for prophylaxis during EUS-FNA of pancreatic cysts., Design: Retrospective cohort study., Patients: This study involved all patients who underwent EUS-FNA of pancreatic cysts at one institution from May 2007 to April 2010., Intervention: Antibiotic prophylaxis for EUS-FNA., Main Outcome Measurements: Infection of a pancreatic cyst, fever, or bacteremia after EUS-FNA. Secondary variables included other complications of the procedure related to the use of prophylaxis (ie, allergic reactions, secondary infections)., Results: EUS-FNA was performed on 253 patients in 266 procedures. Antibiotics were used in 88 endoscopy cases (ATB group), whereas no antibiotics were used in 178 cases (NATB group). There were no differences in patient or cyst characteristics between groups. There were 4 major complications in the NATB group (localized bleeding, 2; pancreatitis, 1; bile leakage, 1) and 2 in the ATB group (possible cyst infection, 1; bile leakage, 1) (P = 1.0). Eight mild adverse events were observed in the NATB group and 6 in the ATB group (P = .56). Infections and antibiotic-related complications occurred in 1 (0.6%) (transient fever) in the NATB group and 4 (4.5%) in the ATB group (local allergic reaction, 2; possible cyst infection, 1; Clostridium difficile diarrhea, 1) (P = .04)., Limitations: Retrospective analysis., Conclusion: The incidence of infectious complications after EUS-FNA of pancreatic cystic lesions, with or without antibiotic prophylaxis, appears very low. We have not observed a protective effect from periprocedural prophylactic antibiotic administration., (Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Secure closure of the colonic access site is one of the most important issues for the development of natural orifice transluminal endoscopic surgery., Objective: To evaluate the feasibility, reproducibility, and efficacy of a new over-the-scope clip., Design: Descriptive study, in vivo porcine colon., Intervention: In 10 female Yorkshire pigs weighing 30 to 35 kg, a 10-mm colotomy was performed by using a needle-knife and advancing the endoscope to the peritoneal cavity. Colonic closure was performed by using the Padlock-G clip (Aponos Medical, Kingston, NH) delivered with the Lock-It system (Aponos)., Main Outcome Measurements: Animals were monitored daily for signs of peritonitis and sepsis over a period of 14 days. During necropsy, the peritoneal cavity was examined, and the colon segment containing the incision was excised for pathological study., Results: Closure was achieved in all cases. Nine of 10 pigs survived 14 days without complications, but 1 pig was killed immediately after the procedure because of severe bleeding during the colonic incision. The median closure time was 8 minutes (range 1-30 minutes). At necropsy, adhesions were observed in 5 cases. The incision was hardly visible at the serosa side in 3 cases and was not identified in 6 cases. In 6 cases, the clip was still slightly attached to the mucosa, and it was not found in 3 cases. The pathological study revealed a complete remodeling of the colonic wall in all cases., Limitations: Animal model, noncomparative study., Conclusion: The Padlock-G clip procedure is feasible, reproducible, effective, and easy to perform, and it provides a reliable colonic closure., (Copyright © 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)