Menu
Not yet recruiting NCT07488299

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

No phase Interventional Pancreatic Walled-off Necrosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Proton Pump Inhibitors.
Who it may be relevant to
Registry conditions: Pancreatic Walled-off Necrosis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Primary outcome measures

  • Total number of interventions [Time frame: Within 6 months after EUS-TD]
Secondary outcome measures (5)
  • Technical Success Rate [Time frame: With 24 hours after EUS-TD]
  • Clinical success rate [Time frame: Within 1 months after EUS-TD]
  • Stent occlusion rate [Time frame: Within 6 months after EUS-TD]
  • Hospitalization and cost [Time frame: Within 6 months after EUS-TD]
  • Incidence of complications [Time frame: Within 6 months after EUS-TD]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Qilu Hospital of Shandong University — Jinan

Identifiers

NCT: NCT07488299 · 2025SDU-QILU-7

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗