Clinical Trial

The Effect of Proton Pump Inhibitors(PPIs) on Endoscopic Treatment of Walled-off Necrosis (WON)

Recruiting
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Summary
In this multicenter, randomized controlled trial, patients with pancreatic walled-off necrosis (WON) based on inclusion and exclusion criteria will be randomly assigned in a 1:1 ratio to either receive intravenous infusion or oral administration of continuous proton pump inhibitors (PPIs) or to undergo no PPI (nPPI) therapy after endoscopic ultrasound-guided transluminal drainage/debridement. Clinical data and patient-reported outcomes will be systematically collected at baseline and during follow-up periods. The study aims to assess whether PPI use after EUS-TD (Endoscopic Ultrasonography-Guided Transmural Drainage) increases the number of direct endoscopic necrosectomies required to managing WON. Additionally, the study will investigate the impact of PPI use on the incidence of stent occlusion and postoperative complications following EUS-TD, as well as its effect on the average duration of hospitalization and associated costs for patients with WON.
Protocol Amendment History 1 change
critical Recruitment opened 2026-08-11
Trial Details
NCT Number NCT07488299
Lead Sponsor Qilu Hospital of Shandong University
Collaborators: 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China, Shandong Provincial Hospital, Shengli Oilfield Hospital, Shenzhen People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Nanfang Hospital, Southern Medical University
Conditions Pancreatic Walled-off Necrosis
Enrollment 120 participants
Start Date 2025-09-17
Primary Completion 2028-03-20 (estimated)
Study Completion 2028-03-20 (estimated)
Updated on ClinicalTrials.gov 2026-08-10