Does giving PPIs after endoscopic draining of pancreatic walled-off necrosis change how treatment proceeds?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized study enrolls adults with pancreatic walled-off necrosis who need endoscopic drainage/debridement. Participants are randomly assigned to receive IV or oral PPIs, or no PPI therapy after the procedure, to see how PPIs affect the number of direct endoscopic necrosectomies, stent occlusion, and postoperative complications. Researchers will collect baseline data and follow-up outcomes, including hospital stay length and costs. The goal is to determine if PPI use after EUS-guided drainage influences clinical course and resource use.

Why it matters

Who can join: the full rules

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.

Where it's running

• Qilu Hospital of Shandong University
  Jinan, Shandong, China Recruiting

Study contacts

• Principal investigator: Ning Zhong, MD — Qilu Hospital of Shandong University
• Study coordinator: Zhen Li, MD
• Email: qilulizhen@sdu.edu.cn
• Phone: 18560086106

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Nasojejunal versus oral feeding after endoscopic drainage of walled-off pancreatic necrosis

  This will see if feeding through a tube into the small intestine (nasojejunal feeding) works better than eating by mouth for adults undergoing endoscopic drainage of walled-off pancreatic necrosis.

  Recruiting Post Graduate Institute of Medical Education and Research, Chandigarh · Chandigarh · NCT07395778

• Cryotechnology for removing necrotic pancreatic tissue

  This study is testing a new freezing technique to see if it can help doctors remove dead tissue from the pancreas more effectively in patients with severe pancreatitis.

  Recruiting Brigham and Women's Hospital · Boston, Massachusetts · NCT06553651

• Early (2-week) versus standard (4-week) metal stent removal after EUS-guided drainage for walled-off pancreatic necrosis.

  This test checks whether removing the metal stent early (at 2 weeks) and placing a double-pigtail plastic drain, versus removing it at the usual 4 weeks without a plastic drain, lowers the chance of fluid collection coming back or needing another procedure in adults with walled-off pancreatic necrosis.

  Recruiting Asian Institute of Gastroenterology, India · Hyderabad, Telangana · NCT07307248

• Comparing immediate necrosectomy to a step-up approach for treating walled-off necrosis

  This study is testing whether a quick procedure to remove walled-off necrosis can help people with symptoms from acute pancreatitis recover faster than the usual step-by-step treatment.

  Recruiting at 13 sites Tokyo University · Bunkyō-Ku, Tokyo and 20 other locations · NCT05451901

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.