Dose-escalation of Rectal Indomethacin for Preventing PEP

Dose-escalation of Rectal Indomethacin for Post-ERCP Pancreatitis Prevention in High-risk Patients: Protocol of a Multicentre Randomised Clinical Trial

Our aim is to compare the efficacy of 100 mg versus 200 mg rectal indometacin in preventing post-ERCP pancreatitis (PEP) among high-risk patients without no pancreatic stenting. The 100 mg versus 200 mg indometacin trial is a multicentre, single-blind, randomized controlled study. High-risk patients for PEP without pancreatic stent insertion will be informed about the opportunity to participate. A total of 1,036 eligible patients will be randomly assigned in a 1:1 ratio to one of two groups: (1) administration of 100 mg rectal indometacin immediately after ERCP (standard-dose group), or (2) administration of 200 mg rectal indometacin immediately after ERCP (high-dose group). The primary outcome is the incidence and severity of PEP. Secondary outcomes include hyperamylasemia and other ERCP-related adverse events (AEs).

Study Overview

• Status: Not yet recruiting
• Conditions: Post-ERCP Pancreatitis
• Intervention / Treatment: Drug: standard-dose group VS high-dose group

Detailed Description

Evidence suggests that escalating the rectal indometacin dose to 200 mg offers no clear advantage over the standard 100 mg regimen in high-risk patients. However, the majority of participants (76%) had received pancreatic stent placement, raising the possibility that the benefit of the supplementary strategy may have been obscured by the considerable efficacy of pancreatic stenting. Our aim is to compare the efficacy of 100 mg versus 200 mg rectal indometacin in preventing post-ERCP pancreatitis (PEP) among high-risk patients without no pancreatic stenting.

• Study Type: Interventional
• Enrollment (Estimated): 1036
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Qiao Mei, MD; Phone Number: 8613865977696; Email: meiqiaomq@aliyun.com
• Study Contact Backup: Name: Junjun Bao, MD; Phone Number: 8613655697005; Email: csbj01@aliyun.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University
      • Contact: Qiming Huang, MD; Phone Number: 8617730145813; Email: qimhuang@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:Participants will be eligible for enrollment if they meet all of the following criteria: 1. age over 18 years; 2. classified as high risk for post-ERCP pancreatitis; 3. provision of signed, written informed consent.

Exclusion Criteria:Participants will be excluded if they meet any of the following conditions: 1. inaccessible major papilla; 2. surgically altered gastrointestinal anatomy; 3. current diagnosis of acute pancreatitis; 4. placement of a pancreatic stent; 5. contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs), including known allergy, renal insufficiency, or active peptic ulcer disease; 6. anticipated low risk of post-ERCP pancreatitis (e.g., patients with chronic calcific pancreatitis, pancreatic head mass, or those undergoing biliary interventions through a pre-existing sphincterotomy); 7.severe active cardiopulmonary disease; 8. pregnancy or breastfeeding; 9. presence of an ampullary tumor.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard-dose group; administration of 100 mg rectal indometacin immediately after ERCP	Drug: standard-dose group VS high-dose group; A total of 1,036 eligible patients will be randomly assigned in a 1:1 ratio to one of two groups: (1) administration of 100 mg rectal indometacin immediately after ERCP (standard-dose group), or (2) administration of 200 mg rectal indometacin immediately after ERCP (high-dose group)
Experimental: high-dose group; administration of 200 mg rectal indometacin immediately after ERCP	Drug: standard-dose group VS high-dose group; A total of 1,036 eligible patients will be randomly assigned in a 1:1 ratio to one of two groups: (1) administration of 100 mg rectal indometacin immediately after ERCP (standard-dose group), or (2) administration of 200 mg rectal indometacin immediately after ERCP (high-dose group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence and severity of PEP	Patients were identified as post-ERCPpancreatitis if meeting two out of three criteria: pain consistent with acute pancreatitis; amylase or lipase>3 times normal limit; characteristic findings on imaging, in according to the Revised Atlanta International consensus.	up to 1 months

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Anhui Medical University
• Investigators: Principal Investigator: Shaofei Wang, Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: ERCP; post-ERCP pancreatitis; indometacin
• Additional Relevant MeSH Terms: Population Characteristics; Demography; Population Groups
• Other Study ID Numbers: FirstHAnhuiMU1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

We are committed to promoting transparency and open science. Upon reasonable request and under certain conditions, individual participant data (IPD) from our study may be shared for further research. Access to the IPD will be considered on a case-by-case basis, following review and approval of a formal proposal by Qiao Mei.

To inquire about accessing the IPD, interested parties may contact Qiao Mei at meiqiaomq@aliyun.com.

Please note that data sharing is contingent upon meeting the criteria for ethical use, privacy, and confidentiality as outlined in our data sharing policy. Additionally, appropriate data transfer agreements may need to be established prior to sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No