The Effect of PPI on Endoscopic Treatment of WON: a Multicenter Randomized Controlled Trial.

NCT07488299 | Not Yet Recruiting

• 1 other identifier: 2025SDU-QILU-7
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

In this multicenter, randomized controlled trial, patients with pancreatic walled-off necrosis 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 inhibitor 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

Keywords

Pancreatic Walled-off Necrosis; Direct Endoscopic Necrosectomy; Proton Pump Inhibitor; Randomized Controlled Trial; Endoscopic Ultrasound-guided Transluminal Drainage/Debridement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Technical Success Rate

  With 24 hours after EUS-TD

• Clinical success rate

  Within 1 months after EUS-TD

• Stent occlusion rate

  Within 6 months after EUS-TD

• Hospitalization and cost

  Within 6 months after EUS-TD

• Incidence of complications

  Within 6 months after EUS-TD

Study Arms (2)

receive continuous proton pump inhibitor therapy following EUS-TD

EXPERIMENTAL

Drug: Proton Pump Inhibitors

No PPI therapy following EUS-TD

NO INTERVENTION

Interventions

Proton Pump Inhibitors DRUG

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

receive continuous proton pump inhibitor therapy following EUS-TD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients diagnosed with chronic pancreatitis who have not experienced an acute pancreatitis attack within the past three months.
• Patients with severe coagulation disorders (International Normalized Ratio \[INR\] \> 1.5).
• Patients with significant thrombocytopenia (platelet count \< 50 × 10\^9/L).
• Pregnant women.
• Patients undergoing endoscopic drainage solely through the duodenum.
• Patients with a history of gastrectomy, gastric bypass surgery, or prior surgery for pancreatic-related diseases.
• 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).
• Patients requiring long-term use of acid-suppressing medications such as PPIs and P-CABs due to other medical conditions.
• Patients with a history of acid-suppressive medication use (e.g., PPI) and a washout period of less than 14 days.
• Patients with documented contraindications to PPIs or a relevant history of hypersensitivity.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• The 960th Hospital of the PLA Joint Logistics Support Force: collaborator
• Shandong Provincial Hospital: collaborator
• Shengli Oilfield Hospital: collaborator
• Shenzhen People's Hospital: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Nanfang Hospital, Southern Medical University: collaborator

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250063, China

Location

MeSH Terms

Interventions

Proton Pump Inhibitors

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Ning Zhong, MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen Li, MD

CONTACT

18560086106; qilulizhen@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): March 20, 2028
• Study Completion (Estimated): March 20, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)