Dose-escalation of Rectal Indomethacin for Preventing PEP

NCT07247682 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: FirstHAnhuiMU1
• Study Type: interventional
• Target: 1,036
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Post-ERCP Pancreatitis

Keywords

post-ERCP pancreatitis; indometacin; ERCP

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

standard-dose group

ACTIVE COMPARATOR

administration of 100 mg rectal indometacin immediately after ERCP

Drug: standard-dose group VS high-dose group

high-dose group

EXPERIMENTAL

administration of 200 mg rectal indometacin immediately after ERCP

Drug: standard-dose group VS high-dose group

Interventions

standard-dose group VS high-dose group DRUG

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)

high-dose group; standard-dose group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University: lead

Study Sites (1)

Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

Location

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Shaofei Wang

  Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiao Mei, MD

CONTACT

8613865977696; meiqiaomq@aliyun.com

Junjun Bao, MD

CONTACT

8613655697005; csbj01@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: For enhanced objectivity in data analysis, the project statisticians will be blinded to the arm allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: November 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)