Comparing Indomethacin and Pancreatic Stenting to Prevent Post ERCP Pancreatitis

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 clinical trial aims to compare the effectiveness of rectally administered indomethacin versus pancreatic duct stenting in preventing post ERCP pancreatitis (PEP) in high-risk patients. PEP is a common complication following endoscopic retrograde cholangiopancreatography (ERCP), and both interventions have shown independent benefits in reducing its incidence. The study will be conducted as a multi-centre randomized controlled trial, enrolling patients with specific risk factors for PEP. By directly comparing these two methods, the trial seeks to determine if one approach is superior or if both are equally effective.

Why it matters

Who can join: the full rules

Inclusion Criteria:

presence of one of the following risk factors for Post ERCP Pancreatitis

1. sphincter of Oddi dysfunction
2. history of PEP, pancreatic instrumentation or sphincterotomy, precut sphincterotomy,
3. difficult cannulation defined by \>5 cannulation attempts
4. the use of double wire technique in bile duct access
5. at least 2 of the followings including i) female age\<50 ii) 3 pancreatograms iii) acinarization (contrast injection to tail fo pancreas). iv） normal bilirubin； v）guidewire to the tail of pancreas or secondary branches.

Exclusion Criteria:

* patients intended for pancreatic stenting e.g. those with pancreatic duct strictures, ampullectomy,
* without informed consents from patient or next of kin
* age \<18
* pregnant or lactating women
* patients with altered anatomy except except Billroth I and II gastrectomy
* contraindications to the use of NSAIDs such as those with active gastrointestinal bleeding, renal failure (serum creatinine \> 140)
* known NSAID allergy
* incipient heart failure.

Where it's running

• Endoscopy centre
  Xi'an, Shaanxi, China Recruiting
• Eastern Hepatobiliary Surgery Hospital,Endoscopy centre
  Shanghai, Shanghai Municipality, China Recruiting
• Endoscopy centre
  Tianjin, Tianjin Municipality, China Recruiting
• Endoscopy centre
  Hangzhou, Zhejiang, China Recruiting
• Endoscopy Centre, Prince of Wales Hospital
  Hong Kong, Hong Kong, Hong Kong Recruiting
• 2. Chulalongkorn University and King Chulalongkorn Memorial Hospital
  Bangkok, Thailand Recruiting

Study contacts

• Principal investigator: James LAU, MD — Chinese University of Hong Kong
• Study coordinator: James LAU, MD
• Email: laujyw@surgery.cuhk.edu.hk
• Phone: 35051411

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

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

  This test sees if a lower rectal dose of indomethacin prevents pancreatitis as well as the standard 100 mg dose in adults undergoing ERCP.

  Recruiting at 3 sites Phase 4 Changhai Hospital · Shanghai and 11 other locations · NCT07088757

• 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

• Can a rectal NSAID alone prevent pancreatitis after ERCP instead of also placing a pancreatic duct stent?

  This trial will see if giving a rectal NSAID by itself prevents pancreatitis after ERCP in high-risk adults as well as giving both a rectal NSAID and a pancreatic duct stent.

  Recruiting at 11 sites Air Force Military Medical University, China · Beijing, Beijing Municipality and 14 other locations · NCT07117318

• Using intravenous fluids to prevent pancreatitis after ERCP procedures

  This study tests if different types of intravenous fluids can help prevent pancreatitis in patients undergoing ERCP procedures.

  Recruiting Phase 4 University of Calgary · Calgary, Alberta · NCT06260878

• Understanding genetic and pharmacokinetic factors in post-ERCP pancreatitis

  This study is trying to find out how genetic factors and how the body processes medications affect the risk of developing pancreatitis after a specific procedure called ERCP.

  Recruiting Radboud University Medical Center · Nijmegen, Gelderland · NCT05267379

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.