Rectal NSAIDs With/Without PD Stent for PEP Prevention

Recruiting now · Not applicable

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

In brief

Pancreatitis is the most common and serious complication following post-endoscopic retrograde cholangiopancreatography (ERCP) and is associated with occasional mortality, extended hospital stays, and increased healthcare expenses. Rectal non-steroidal anti-inflammatory drugs (NSAIDs) and pancreatic duct stent (PDS) placement were demonstrated to be effective strategyies to reduce PEP incidences, particlularly in high-risk patients for post-ERCP pancreatitis (PEP). Rectal NSAIDs were easy-to-use and safe, while PDS placement were technically complex and carried higher risks of adverse events. A previous network meta-analysis suggested rectal NSAIDs in combination with PDS placement did not differ from rectal NSAIDs alone in PEP prevention. To invesigate if rectal NSAIDs alone could obivate the need of PDS placement, a recent trial from Elmunzer et al. conducted a randomized trial to investigate if rectal NSAIDs alone was non-inferior to the combination of NSAIDs with PDS in high-risk patients. The trial found that the PEP incidence rate in combination group was significantly lower than that in NSAIDs alone group. However, post-hoc analysis of the study suggested that the combination strategy conferred significant benefits only in high-risk patients with pancreatic duct (PD) wire passage, but not in those with other risk factors. Therefore, we hypothesized that rectal NSAIDs alone may obivate the need of PDS in high-risk patients without PD wire passages. Here, we conducted a multicenter, randomized and non-inferiority trial to investigate whether rectal NSAIDs alone is non-inferior to NSAIDs plus PDS placement in high-risk patients without PD wire passages.

Key facts

Study ID: NCT07117318
Run by: Air Force Military Medical University, China
People needed: 1278
Starts: 2025-07-01
Expected to finish: 2028-06-01
Last updated by the study team: 2025-12-03

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 is running

Department of Gastroenterology, Fujian Medical University Xiamen Humanity Hospital — Xiamen, Fujian, China (enrolling)
Department of Endoscopy, Eastern Hepatobiliary Hospital, Second Military Medical University — Shanghai, Shanghai Municipality, China (enrolling)
Harbin Medical University Affiliated Fourth Hospital — Harbin, Heilongjiang, China (enrolling)
the First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)
The Second Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (enrolling)
Department of Gastroenterology, Huaihe Hospital of Henan University — Kaifeng, Henan, China (enrolling)
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (enrolling)
986 Hospital of Xijing Hospital — Xi'an, Shaanxi, China (enrolling)
Xijing of Digestive Diseases — Xi'an, Shaanxi, China (enrolling)
Department of Gastroenterology, The 960th Hospital of the PLA — Jinan, Shandong, China (enrolling)
The Third Xiangya Hospital of Central South University — Changsha, Hunan, China
The first medical center, Chinese PLA General Hospital — Beijing, Beijing Municipality, China
Shandong Provincial Third Hospital — Jinan, Shandong, China
Affiliated Hangzhou First People's Hospital — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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