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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Walled-off Necrosis
• Intervention / Treatment: Drug: Proton Pump Inhibitors

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhen Li, MD; Phone Number: 18560086106; Email: qilulizhen@sdu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250063
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: Zhen Li, MD; Phone Number: 18560086106; Email: qilulizhen@sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients aged 18 years or older and not exceeding 80 years of age.
2. Patients with a confirmed diagnosis of WON.
3. Patients requiring endoscopic ultrasound-guided transluminal drainage/debridement therapy.
4. Patients who have signed informed consent forms.

Exclusion Criteria:

1. Patients diagnosed with chronic pancreatitis who have not experienced an acute pancreatitis attack within the past three months.
2. Patients with severe coagulation disorders (International Normalized Ratio [INR] > 1.5).
3. Patients with significant thrombocytopenia (platelet count < 50 × 10^9/L).
4. Pregnant women.
5. Patients undergoing endoscopic drainage solely through the duodenum.
6. Patients with a history of gastrectomy, gastric bypass surgery, or prior surgery for pancreatic-related diseases.
7. Patients currently taking medications that may affect gastric acid secretion or metabolism, such as strong cytochrome P450 (CYP) 3A4 inhibitors (e.g., clarithromycin, itraconazole) or inducers (e.g., rifampin, carbamazepine).
8. Patients requiring long-term use of acid-suppressing medications such as PPIs and P-CABs due to other medical conditions.
9. Patients with a history of acid-suppressive medication use (e.g., PPI) and a washout period of less than 14 days.
10. Patients with documented contraindications to PPIs or a relevant history of hypersensitivity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: receive continuous proton pump inhibitor therapy following EUS-TD	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.
No Intervention: No PPI therapy following EUS-TD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of interventions	The total number of endoscopic interventions required to achieve successful WON treatment, including reinterventions, stents removal, and any other interventions performed during the 6-month follow-up period to manage adverse events or disease-specific events.	Within 6 months after EUS-TD

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success Rate	Successfully placed stents to drain WON.	With 24 hours after EUS-TD
Clinical success rate	The lesion size has decreased by more than 50% compared to preoperative measurements, with concurrent symptom relief. No further intervention is required prior to stents removal.	Within 1 months after EUS-TD
Stent occlusion rate	The stent lumen is obstructed by necrotic tissue, debris, or blood clots, leading to impaired drainage and necessitating reintervention, such as stent replacement or direct endoscopic necrosectomy.	Within 6 months after EUS-TD
Hospitalization and cost	The hospitalization duration, ICU stay duration, and hospitalization costs related to WON treatment	Within 6 months after EUS-TD
Incidence of complications	Bleeding, perforation, secondary infection, incidence and duration of new organ dysfunction, and mortality associated with EUS-TD.	Within 6 months after EUS-TD

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Collaborators: Shandong Provincial Hospital; Shenzhen People's Hospital; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Shengli Oilfield Hospital; Nanfang Hospital, Southern Medical University; 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China
• Investigators: Principal Investigator: Ning Zhong, MD, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2025
• Primary Completion (Estimated): March 20, 2028
• Study Completion (Estimated): March 20, 2028

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): August 10, 2026
• Last Update Submitted That Met QC Criteria: August 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Proton Pump Inhibitor; Direct Endoscopic Necrosectomy; Pancreatic Walled-off Necrosis; Endoscopic Ultrasound-guided Transluminal Drainage/Debridement
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Pharmacologic Actions; Chemical Actions and Uses; Proton Pump Inhibitors
• Other Study ID Numbers: 2025SDU-QILU-7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No