NCT07488299

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

RecruitingNA

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.

At a glance

Conditions: Pancreatic Walled-off Necrosis
Interventions: Proton Pump Inhibitors
Lead sponsor: Qilu Hospital of Shandong University
Target enrollment: 120 participants
Age: 18 Years – 80 Years
Sex: ALL
Locations: Qilu Hospital of Shandong University
Registry: View on ClinicalTrials.gov ↗

Eligibility criteria

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.