Use of over-the-scope clip (OTSC) versus standard therapy for the prevention of rebleeding in large peptic ulcers (size ≥1.5 cm): an open-labelled, multicentre international randomised controlled trial.

INTRODUCTION: Over-the-scope clip (OTSC) has been used recently for primary haemostasis of peptic ulcers. This study aimed to compare the efficacy of OTSC to standard endoscopic therapy in primary treatment of patients with peptic ulcer bleeding that are of size ≥1.5 cm. The target population accounts for only 2.5% of all upper GI bleeders. METHODS: This was a multicentre international randomised controlled trial from July 2017 to October 2020. All patients with Forest IIa or above peptic ulcers of ≥1.5 cm were included. Primary outcome was 30-day clinical rebleeding. Secondary endpoints include 3-day all-cause mortality, transfusion requirement, hospital stay, technical and clinical success, and further interventions. 100 patients are needed to yield a power of 80% to detect a difference of -0.15 at the 0.05 significance level (alpha) using a two-sided Z-test (pooled). RESULTS: 100 patients were recruited. Success in achieving primary haemostasis was achieved in 46/50 (92%) and 48/50 (96%) in the OTSC and conventional arm, respectively. Among patients who had success in primary haemostasis, 2/46 (4.35%) patients in the OTSC arm and 9/48 (18.75%) patients in the conventional arm developed 30-day rebleeding (p=0.03). However, in an intention-to-treat analysis, there was no difference in rebleeding within 30 days (5/50 (10%) OTSC vs 9/50 (18%) standard, p=0.23) or all-cause mortality (2/50 (4%) OTSC vs 4/50 (8%) standard, p=0.68; OR=2.09, 95% CI 0.37 to 11.95). There was also no difference in transfusion requirement, hospital stay, intensive care unit admission and further interventions. CONCLUSION: The routine use of OTSC as primary haemostasis in large bleeding peptic ulcers was not associated with a significant decrease in 30-day rebleeding. TRIAL REGISTRATION NUMBER: NCT03160911.

Efficacy and safety of novel digital single-operator peroral cholangioscopy-guided laser lithotripsy for complicated biliary stones.

Background/study aims Laser lithotripsy can effectively fragment complicated biliary stones, but current cholangioscopes are limited by fragility, restricted mobility or moderate visual resolution. The efficacy and safety of a new digital single-operator peroral cholangioscope to guide laser lithotripsy were evaluated. Patients and methods In this prospective single-center series, consecutive patients with complicated biliary stones, defined as impacted stones > 1.5 cm in size and wider than the more distal common bile duct, or stones that failed extraction by basket mechanical lithotripsy, underwent ERCP and SpyGlass DS peroral cholangioscope (Boston Scientific, Marlborough, United States)-guided laser lithotripsy. Stone clearance rate and incidence of adverse events were determined. Results Seventeen patients (10 men, 7 women; median age 76 years) with a median biliary stone size of 2 cm underwent predominantly holmium:yttrium aluminum garnet laser lithotripsy, achieving a 94 % stone clearance rate over 1 median procedure. Lithotripsy was performed in 8 of 17 patients due to an impacted biliary stone. The remaining patients underwent lithotripsy due to prior failure of the basket mechanical lithotripter to capture or crush their stones. Post lithotripsy, 2 patients developed cholangitis and 1 patient with underlying COPD developed respiratory distress, all resolved with conservative management. There were no hemobilia, perforations, pancreatitis nor any deaths. Conclusion SpyGlass DS peroral cholangioscopy-guided laser lithotripsy is an efficient and safe modality for management of complicated biliary stones.