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Introduction: Gastrointestinal bleeding is a life-threatening complication in patients undergoing extracorporeal membrane oxygenation support. Despite data on increased mortality due to gastrointestinal bleeding, there is little data on the treatment of such conditions under extracorporeal membrane oxygenation, and on the possibilities of advanced endoscopic therapy to non-invasively solve these bleeding complications. No clear treatment in the case of extracorporeal membrane oxygenation support is recommended in the guidelines. Methods: Retrospective observational cohort study including 134 veno-venous extracorporeal membrane oxygenation patients for acute respiratory failure from 2009 to 2018 at IRCCS-ISMETT (Italy). Patients were divided into two groups according to gastrointestinal bleeding episodes and reviewed for type of endoscopic therapy. Gastrointestinal bleeding group was characterized for pre–extracorporeal membrane oxygenation characteristics, management variables—including amount of transfusions and clinical outcomes. Results: Fourteen (14) patients (10.4%) experienced upper (n = 13) or lower (n = 1) gastrointestinal bleeding. Gastrointestinal bleeding and no-gastrointestinal bleeding group had similar characteristics apart from higher creatinine in the gastrointestinal bleeding group (1.9 mg/dL (1.3-4.9) vs 1.2 mg/dL (0.7-1.8), p = 0.03). In 3 of the 14 patients (21%), endoscopy showed no signs of active bleeding (nasogastric or feeding tube decubitus), and no specific intervention was performed. Active bleeding was recognized in 11 of the 14 patients (79 %). No patients died of fatal bleeding in the gastrointestinal bleeding group. Endoscopic therapy was feasible, with a complete bleeding control in all the cases: five Hemospray®, two fibrin glue, two metallic clips, one combined approach metallic clips with epinephrine, and one cyanoacrylate. The extracorporeal membrane oxygenation course was significantly longer in the gastrointestinal bleeding group: 19.5 (15-36) days vs 13.5 (8-25) days, p = 0.01. No significant differences in mortality were found between the two groups (all p values > 0.05). Conclusion: Advanced endoscopic therapy during veno-venous extracorporeal membrane oxygenation may contribute to reducing the negative effects on mortality for gastrointestinal bleeding episodes.

Background and Aims: The benefit of rapid on-site evaluation (ROSE) on the diagnostic accuracy of endoscopic ultrasound–guided fine-needle biopsy (EUS-FNB) has never been evaluated in a randomized study. This trial aimed to test the hypothesis that in solid pancreatic lesions (SPLs), diagnostic accuracy of EUS-FNB without ROSE was not inferior to that of EUS-FNB with ROSE. Methods: A noninferiority study (noninferiority margin, 5%) was conducted at 14 centers in 8 countries. Patients with SPLs requiring tissue sampling were randomly assigned (1:1) to undergo EUS-FNB with or without ROSE using new-generation FNB needles. The touch-imprint cytology technique was used to perform ROSE. The primary endpoint was diagnostic accuracy, and secondary endpoints were safety, tissue core procurement, specimen quality, and sampling procedural time. Results: Eight hundred patients were randomized over an 18-month period, and 771 were analyzed (385 with ROSE and 386 without). Comparable diagnostic accuracies were obtained in both arms (96.4% with ROSE and 97.4% without ROSE, P = .396). Noninferiority of EUS-FNB without ROSE was confirmed with an absolute risk difference of 1.0% (1-sided 90% confidence interval, –1.1% to 3.1%; noninferiority P < .001). Safety and sample quality of histologic specimens were similar in both groups. A significantly higher tissue core rate was obtained by EUS-FNB without ROSE (70.7% vs. 78.0%, P = .021), with a significantly shorter mean sampling procedural time (17.9 ± 8.8 vs 11.7 ± 6.0 minutes, P < .0001). Conclusions: EUS-FNB demonstrated high diagnostic accuracy in evaluating SPLs independently on execution of ROSE. When new-generation FNB needles are used, ROSE should not be routinely recommended. (ClinicalTrial.gov number NCT03322592.)

Background and study aims Exposed endoscopic full-thickness resection (Eo-EFTR) without laparoscopic assistance is a minimally invasive natural orifice transluminal endoscopic surgery (NOTES) technique that has shown promising efficacy and safety in resection of gastric submucosal tumors (G-SMTs) arising from muscularis propria (MP). However, data on the efficacy and safety of gastric Eo-EFTR mostly come from relatively small retrospective studies and concern regarding its use still exists. The aim of our systematic review was to assess the efficacy and safety of gastric Eo-EFTR without laparoscopic assistance. Methods A detailed MEDLINE and EMBASE search was performed for papers published from January 1998 to November 2019 and reporting on gastric Eo-EFTR without laparoscopic assistance. The search strategy used the terms “endoscopic full thickness resection” and “gastric” or “stomach”. The primary outcomes were complete resection and surgical conversion rates. The secondary outcomes were overall major adverse events, delayed bleeding, delayed perforation, peritonitis, abdominal abscess and/or abdominal infection and successful Eo-EFTR. Results Fifteen Asian studies were included in our final review, providing data on 750 Eo-EFTR-treated G-SMTs. The per-lesion rate of complete resection and surgical conversion were 98.8 %\0.8 %, respectively. The per-lesion rate of major adverse events, delayed bleeding, delayed perforation and peritonitis, abdominal abscess and/or abdominal infection was 1.6 %\0.5 %\0.1 %\0.9 %, respectively. The per-lesion rate of successful Eo-EFTR (i. e. complete tumor resection and effective endoscopic defect closure) was 98.3 %. Conclusions Eo-EFTR without laparoscopic assistance appears to be highly effective and safe NOTES for removing deep G-SMTs, particularly those arising from MP layer.