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

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

High-risk adults undergoing ERCP are assigned to receive either a rectal nonsteroidal anti-inflammatory drug (NSAID) alone or a rectal NSAID plus a prophylactic pancreatic duct stent. The trial compares rates of post-ERCP pancreatitis and procedure-related complications between the two groups. Participating centers are tertiary hospitals in China, and enrollment focuses on patients with native papilla who meet predefined high-risk criteria. The goal is to determine whether the simpler, lower-risk NSAID-only approach can provide similar protection against post-ERCP pancreatitis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18-90 years old patients with native papilla who planned to undergo ERCP
* high-risk patients for post-ERCP pancreatitis must meet one or more following criteria: clinical suspicion of sphincter of Oddi dysfunction, a history of PEP, pancreatic sphincterotomy, precut sphincterotomy, difficult cannulation (\>5 cannulation attempts, or \>5mins cannulation time, or \>1 unintentional pancreatic duct cannulation), or ballon dilatation of an intact biliary sphincter ≤ 1 min, double-wire cannulation. Additionally, patients were considered high-risk if they fulfilled two or more of the following minor criteria: female gender under 50 years old, a history of recurrent pancreatitis (two or more episodes), three or more contrast injections into the pancreatic duct with at least one injection reaching the tail of the pancreas, opacification of pancreatic acini, or brush cytology performed on the pancreatic duct.

Exclusion Criteria:

* Previous biliary sphincterotomy and papillary large balloon dilation
* Planned for placements of pancreatic duct stents (eg. pancreatic duct strictures, planned ampullectomy)
* Allergy to NSAIDs
* The administration of NSAIDs within 7 days
* 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 7 days before ERCP or acute pancreatitis with obvious Pancreatic edema and peripancreatic fluid collections
* Hemodynamical instability
* Pregnancy or lactation
* high-risk patients with pancreatic duct wire passages

Where it's running

• Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University
  Chongqing, Chongqing Municipality, China Recruiting
• Department of Gastroenterology, Fujian Medical University Xiamen Humanity Hospital
  Xiamen, Fujian, China Recruiting
• Harbin Medical University Affiliated Fourth Hospital
  Harbin, Heilongjiang, China Recruiting
• The Second Affiliated Hospital of Harbin Medical University
  Harbin, Heilongjiang, China Recruiting
• Department of Gastroenterology, Huaihe Hospital of Henan University
  Kaifeng, Henan, China Recruiting
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

Similar studies

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

• 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

• Using Tacrolimus and Indomethacin to Prevent Pancreatitis After ERCP

  This study is testing if taking a medication called tacrolimus before a procedure to remove bile duct stones can help prevent pancreatitis in patients.

  Recruiting at 2 sites Phase 3 Johns Hopkins University · Baltimore, Maryland and 4 other locations · NCT05252754

• 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

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.