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The Effect of Proton Pump Inhibitors on Endoscopic Treatment of Walled-off Necrosis: a Multicenter Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Patients aged 18 years or older and not exceeding 80 years of age.

• Patients with a confirmed diagnosis of WON.

• Patients requiring endoscopic ultrasound-guided transluminal drainage/debridement therapy.

• Patients who have signed informed consent forms.

Locations
Other Locations
China
Qilu Hospital of Shandong University
RECRUITING
Jinan
Contact Information
Primary
Zhen Li, MD
qilulizhen@sdu.edu.cn
18560086106
Time Frame
Start Date: 2025-09-17
Estimated Completion Date: 2028-03-20
Participants
Target number of participants: 120
Treatments
Experimental: receive continuous proton pump inhibitor therapy following EUS-TD
No_intervention: No PPI therapy following EUS-TD
Related Therapeutic Areas
Sponsors
Leads: Qilu Hospital of Shandong University
Collaborators: Shenzhen People's Hospital, Nanfang Hospital, Southern Medical University, 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shengli Oilfield Hospital, Shandong Provincial Hospital

This content was sourced from clinicaltrials.gov

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