Low-dose versus standard-dose indomethacin to prevent pancreatitis after ERCP

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, interventional Phase 4 study compares a lower dose of rectal indomethacin with the standard 100 mg dose given before ERCP to prevent post-ERCP pancreatitis (PEP). Adult patients scheduled for ERCP at participating Shanghai hospitals will receive either the low-dose or standard-dose indomethacin prior to the procedure. Key outcomes include the incidence of PEP and rates of NSAID-related adverse events such as gastrointestinal bleeding and renal impairment. Patients with NSAID contraindications, recent NSAID use, active GI bleeding, significant renal dysfunction, pregnancy, or recent acute pancreatitis are excluded.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged 18 years or older.
* Patients planned to undergo Endoscopic Retrograde Cholangiopancreatography

Exclusion Criteria:

* Standard contraindications to ERCP
* Allergy to Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
* Use of NSAIDs within 7 days prior to ERCP
* Not suitable for NSAIDs administration (gastrointestinal hemorrhage within 4 weeks, renal dysfunction \[Cr \>1.4mg/dl=120umol/l\]; presence of coagulopathy before the procedure)
* Acute pancreatitis within 3 days before ERCP
* Hemodynamic instability
* Pregnancy or lactation
* Patients who are unwilling or unable to provide informed consent

Where it's running

• Ruijin Hospital
  Shanghai, China Recruiting
• Sir Run Run Shaw Hospital
  Zhejiang, China Recruiting
• Taizhou Enze Medical Center Group
  Zhejiang, China Recruiting
• Changhai Hospital
  Shanghai, China Not yet recruiting
• Shanghai General Hospital
  Shanghai, China Not yet recruiting
• Affiliated Hospital of Jiaxing University
  Zhejiang, China Not yet recruiting

Study contacts

• Study coordinator: Liang-Hao Hu
• Email: lianghao-hu@hotmail.com
• Phone: +8613817593520

Similar studies

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

• Short-stay aggressive hydration to prevent post-ERCP pancreatitis

  This trial tests whether a short, high-volume IV hydration with Lactated Ringer's plus a rectal indomethacin can prevent post-ERCP pancreatitis in adults undergoing ERCP.

  Recruiting Westmead Hospital · Westmead, New South Wales · NCT07776561

• Comparing early and late pancreatic stent placement to prevent post-ERCP pancreatitis

  This study is testing whether placing a pancreatic stent right after a procedure or later can help prevent pancreatitis in patients who have a difficult time with bile duct access.

  Recruiting The First Affiliated Hospital of Anhui Medical University · Hefei, Anhui and 1 other locations · NCT06250803

• Comparing Indomethacin and Pancreatic Stenting to Prevent Post ERCP Pancreatitis

  This study is testing whether giving indomethacin through the rectum or using pancreatic stenting is better at preventing pancreatitis after a procedure called ERCP in patients who are at high risk for this complication.

  Recruiting at 6 sites Phase 3 Chinese University of Hong Kong · Xi'an, Shaanxi and 6 other locations · NCT03713879

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.