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

Rectal Non-steroid Anti-inflammatory Drugs With or Without Prophylactic Pancreatic Duct Stent for Prevention of Post-ERCP Pancreatitis: a Multicenter, Randomized, Non-inferiority Trial

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.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1278 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Air Force Military Medical University, China (other)
• Locations: 15 sites (Beijing, Beijing Municipality and 14 other locations)
• Trial ID: NCT07117318 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–90 with a native papilla scheduled for ERCP who meet the trial's high-risk criteria for post-ERCP pancreatitis are ideal candidates.

Not a fit: Patients with prior biliary sphincterotomy, other listed exclusions, or those not meeting the high-risk criteria are unlikely to benefit from the trial's approach.

Why it matters

Potential benefit: If successful, patients could avoid the technical risks, extra procedure time, and stent-related complications while maintaining similar protection against post-ERCP pancreatitis.

How similar studies have performed: Prior trials and meta-analyses have shown rectal NSAIDs reduce post-ERCP pancreatitis and suggested that adding a pancreatic stent may not add clear benefit, with at least one randomized trial supporting NSAID-alone strategies.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 14 other locations

• The first medical center, Chinese PLA General Hospital — Beijing, Beijing Municipality, China (NOT_YET_RECRUITING)
• 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)
• The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (NOT_YET_RECRUITING)
• 986 Hospital of Xijing Hospital — Xi'an, Shaanxi, China (RECRUITING)
• Xijing of Digestive Diseases — Xi'an, Shaanxi, China (RECRUITING)
• Department of Gastroenterology, The 960th Hospital of the PLA — Jinan, Shandong, China (RECRUITING)
• Shandong Provincial Third Hospital — Jinan, Shandong, China (NOT_YET_RECRUITING)
• Department of Endoscopy, Eastern Hepatobiliary Hospital, Second Military Medical University — Shanghai, Shanghai Municipality, China (RECRUITING)
• Affiliated Hangzhou First People's Hospital — Hangzhou, Zhejiang, China (NOT_YET_RECRUITING)
• the First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)

Conditions: Post-ERCP Acute Pancreatitis, Non-steroid Anti-inflammatory Drugs, Pancreatic Duct Stent Placement