Rectal NSAIDs With/Without PD Stent for PEP Prevention

NCT07117318 | Recruiting DMC

• 1 other identifier: KY20252177-F-1
• Study Type: interventional
• Target: 1,278
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

Post-ERCP Acute Pancreatitis; Non-steroid Anti-inflammatory Drugs; Pancreatic Duct Stent Placement

Outcome Measures

Primary Outcomes (1)

• Rate of post-ERCP Pancreatitis

  a new or aggravated upper abdominal pain, with an elevated pancreatic enzyme of at least 3 times as the upper limit of normal value 24h after procedure and prolonged hospitalization days for at least 2 days. This definition was based on a widely recognized Cotton consensus

  30 days

Secondary Outcomes (7)

• Rate of mild, moderate or severe PEP

  30 days

• Rate of patients with different severity of pancreatitis evaluated by revised Atlanta criteria

  30 days

• Rate of ERCP-related perforation

  30 days

• Rate of ERCP-related infection

  30 days

• Rate of ERCP-related bleeding

  30 days

Study Arms (2)

NSAIDs alone

EXPERIMENTAL

All patients without contraindications should receive 100mg rectal indomethacin or diclofenac within 30mins before ERCP procedure

Drug: NSAIDs

NSAIDs plus PDS

ACTIVE COMPARATOR

All patients without contraindications should receive 100mg rectal indomethacin or diclofenac within 30mins before ERCP procedure. When eligibility is met, PDS placement will be performed by ERCP colonoscopists.

Device: NSAIDs plus PDS

Interventions

NSAIDs DRUG

All patients without contraindications should receive 100mg rectal indomethacin or diclofenac within 30mins before ERCP procedure

NSAIDs alone

NSAIDs plus PDS DEVICE

All patients without contraindications should receive 100mg rectal indomethacin or diclofenac within 30mins before ERCP procedure. When eligibility is met, PDS placement will be performed by ERCP colonoscopists.

NSAIDs plus PDS

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (15)

The first medical center, Chinese PLA General Hospital

Beijing, Beijing Municipality, 100000, China

NOT YET RECRUITING

Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

Department of Gastroenterology, Fujian Medical University Xiamen Humanity Hospital

Xiamen, Fujian, 361000, China

RECRUITING

Harbin Medical University Affiliated Fourth Hospital

Harbin, Heilongjiang, 150000, China

RECRUITING

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

RECRUITING

Department of Gastroenterology, Huaihe Hospital of Henan University

Kaifeng, Henan, 475000, China

RECRUITING

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

NOT YET RECRUITING

986 Hospital of Xijing Hospital

Xi'an, Shaanxi, 710000, China

RECRUITING

Xijing of Digestive Diseases

Xi'an, Shaanxi, China

RECRUITING

Department of Gastroenterology, The 960th Hospital of the PLA

Jinan, Shandong, 250000, China

RECRUITING

Shandong Provincial Third Hospital

Jinan, Shandong, 250000, China

NOT YET RECRUITING

Department of Endoscopy, Eastern Hepatobiliary Hospital, Second Military Medical University

Shanghai, Shanghai Municipality, 201823, China

RECRUITING

Affiliated Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310000, China

NOT YET RECRUITING

the First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (5)

• Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.

  PMID: 31863440 BACKGROUND

• Elmunzer BJ, Foster LD, Serrano J, Cote GA, Edmundowicz SA, Wani S, Shah R, Bang JY, Varadarajulu S, Singh VK, Khashab M, Kwon RS, Scheiman JM, Willingham FF, Keilin SA, Papachristou GI, Chak A, Slivka A, Mullady D, Kushnir V, Buxbaum J, Keswani R, Gardner TB, Forbes N, Rastogi A, Ross A, Law J, Yachimski P, Chen YI, Barkun A, Smith ZL, Petersen B, Wang AY, Saltzman JR, Spitzer RL, Ordiah C, Spino C, Durkalski-Mauldin V; SVI Study Group. Indomethacin with or without prophylactic pancreatic stent placement to prevent pancreatitis after ERCP: a randomised non-inferiority trial. Lancet. 2024 Feb 3;403(10425):450-458. doi: 10.1016/S0140-6736(23)02356-5. Epub 2024 Jan 11.

  PMID: 38219767 BACKGROUND

• Han S, Zhang J, Durkalski-Mauldin V, Foster LD, Serrano J, Cote GA, Bang JY, Varadarajulu S, Singh VK, Khashab M, Kwon RS, Scheiman JM, Willingham FF, Keilin SA, Groce JR, Lee PJ, Krishna SG, Chak A, Slivka A, Mullady D, Kushnir V, Buxbaum J, Keswani R, Gardner TB, Wani S, Edmundowicz SA, Shah RJ, Forbes N, Rastogi A, Ross A, Law J, Yachimski P, Chen YI, Barkun A, Smith ZL, Petersen BT, Wang AY, Saltzman JR, Spitzer RL, Spino C, Elmunzer BJ, Papachristou GI; SVI Study Group. Impact of difficult biliary cannulation on post-ERCP pancreatitis: secondary analysis of the stent versus indomethacin trial dataset. Gastrointest Endosc. 2025 Mar;101(3):617-628. doi: 10.1016/j.gie.2024.10.003. Epub 2024 Oct 9.

  PMID: 39389431 BACKGROUND

• Akbar A, Abu Dayyeh BK, Baron TH, Wang Z, Altayar O, Murad MH. Rectal nonsteroidal anti-inflammatory drugs are superior to pancreatic duct stents in preventing pancreatitis after endoscopic retrograde cholangiopancreatography: a network meta-analysis. Clin Gastroenterol Hepatol. 2013 Jul;11(7):778-83. doi: 10.1016/j.cgh.2012.12.043. Epub 2013 Jan 30.

  PMID: 23376320 BACKGROUND

• Halttunen J, Keranen I, Udd M, Kylanpaa L. Pancreatic sphincterotomy versus needle knife precut in difficult biliary cannulation. Surg Endosc. 2009 Apr;23(4):745-9. doi: 10.1007/s00464-008-0056-0. Epub 2008 Jul 23.

  PMID: 18649101 BACKGROUND

MeSH Terms

Interventions

Anti-Inflammatory Agents, Non-Steroidal

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 3, 2025

Record last verified: 2025-12

Locations

CN (15)