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

NCT07488299 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-08-10

No results posted yet for this study

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.

Conditions

  • Pancreatic Walled-off Necrosis

Interventions

DRUG

Proton Pump Inhibitors

On the day of endoscopic ultrasound-guided transluminal drainage/debridement, patients initiated proton pump inhibitor therapy via intravenous infusion or oral administration.

Sponsors & Collaborators

  • 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China

    collaborator OTHER

  • Shandong Provincial Hospital

    collaborator OTHER_GOV

  • Shengli Oilfield Hospital

    collaborator OTHER

  • Shenzhen People's Hospital

    collaborator OTHER

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Nanfang Hospital, Southern Medical University

    collaborator OTHER

  • Qilu Hospital of Shandong University

    lead OTHER

Principal Investigators

  • Ning Zhong, MD · Qilu Hospital of Shandong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-17
Primary Completion
2028-03-20
Completion
2028-03-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07488299 on ClinicalTrials.gov