Low-Dose vs Standard-Dose Indomethacin for Preventing Post-ERCP Pancreatitis

NCT07088757 | Recruiting Phase 4 DMC

• 1 other identifier: INSPIRE
• Study Type: interventional
• Target: 1,366
• Locations: 1 country
• Sites: 12

Brief Summary

Endoscopic Retrograde Cholangiopancreatography (ERCP) is a widely used procedure for diagnosing and treating pancreatic and biliary diseases. Despite its benefits, ERCP carries a risk of post-procedure pancreatitis (PEP), which occurs in approximately 12.2% of cases and can significantly increase healthcare costs and patient morbidity. Preventing PEP is crucial for improving patient outcomes and reducing the economic burden of ERCP. Nonsteroidal anti-inflammatory drugs (NSAIDs), such as indomethacin, have been shown to be effective in reducing the incidence of PEP when administered rectally before ERCP. The standard dose recommended by guidelines is 100mg, which has been associated with a significant reduction in PEP rates. However, higher doses of NSAIDs can increase the risk of adverse events, including gastrointestinal bleeding and renal impairment. Therefore, there is a need to determine whether a lower dose can provide similar benefits without increasing these risks. This multicenter, non-inferiority, double-blind, randomized controlled trial will be conducted in China. Participants will be adults aged 18 or older scheduled for ERCP. They will be randomly assigned in a 1:1 ratio to either the low-dose (50mg) or standard-dose (100mg) indomethacin group. The intervention will be administered rectally 30 minutes before the ERCP procedure. The study will follow a double-blind design, ensuring that both patients and investigators are unaware of the treatment allocation. The results of this trial could significantly influence clinical practice by providing evidence on the effectiveness of a lower dose of indomethacin in preventing PEP. This could lead to a reduction in the risk of adverse events associated with higher doses and potentially decrease healthcare costs without compromising patient safety. By optimizing the dosing of indomethacin, this study aims to improve the safety and cost-effectiveness of ERCP procedures.

Conditions

Post-ERCP Pancreatitis

Outcome Measures

Primary Outcomes (1)

• The Proportion of Subjects in Each Study Group With Post-ERCP Pancreatitis

  Within 48 hours after ERCP

Secondary Outcomes (6)

• The Proportion of Subjects in Each Study Group With Moderate-severe Post-ERCP Pancreatitis

  Within one month of ERCP

• Rate of Overall ERCP-related complications

  Within one month of ERCP

• Rate of ERCP-related perforation

  Within one month of ERCP

• Rate of ERCP-related infection

  Within one month of ERCP

• Rate of ERCP-related bleeding

  Within one month of ERCP

Study Arms (2)

low dose indomethacin

EXPERIMENTAL

patients randomized to this intervention receive 50mg indomethacin

Drug: low dose indomethacin

standard dose indomethacin

ACTIVE COMPARATOR

patients randomized to this intervention receive 100mg indomethacin

Drug: standard dose indomethacin

Interventions

standard dose indomethacin DRUG

Patients randomized to this intervention receive 100mg indomethacin suppositories within 30 min before ERCP.

standard dose indomethacin

low dose indomethacin DRUG

Patients randomized to this intervention receive 50mg indomethacin suppositories within 30 min before ERCP.

low dose indomethacin

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years or older.
• Patients planned to undergo Endoscopic Retrograde Cholangiopancreatography

You may not qualify if:

• Standard contraindications to ERCP
• Allergy to Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
• Use of NSAIDs within 7 days prior to ERCP
• 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 3 days before ERCP
• Hemodynamic instability
• Pregnancy or lactation
• Patients who are unwilling or unable to provide informed consent

Sponsors & Collaborators

• Changhai Hospital: lead
• Sir Run Run Shaw Hospital: collaborator
• Ruijin Hospital: collaborator
• Shanghai General Hospital, China: collaborator
• Jinhua Central Hospital: collaborator
• Taizhou Enze Medical Center Group: collaborator
• Dongyang People's Hospital: collaborator
• Shaoxing People's Hospital: collaborator
• First Affiliated Hospital of Ningbo University: collaborator
• Affiliated Hospital of Jiaxing University: collaborator
• People's Hospital of Quzhou: collaborator
• Zhuji People's Hospital of Zhejiang Province: collaborator

Study Sites (12)

Changhai Hospital

Shanghai, China

NOT YET RECRUITING

Ruijin Hospital

Shanghai, China

RECRUITING

Shanghai General Hospital

Shanghai, China

NOT YET RECRUITING

Affiliated Hospital of Jiaxing University

Zhejiang, China

NOT YET RECRUITING

Dongyang People's Hospital

Zhejiang, China

NOT YET RECRUITING

First Affiliated Hospital of Ningbo University

Zhejiang, China

NOT YET RECRUITING

Jinhua Central Hospital

Zhejiang, China

NOT YET RECRUITING

People's Hospital of Quzhou

Zhejiang, China

NOT YET RECRUITING

Shaoxing People's Hospital

Zhejiang, China

NOT YET RECRUITING

Sir Run Run Shaw Hospital

Zhejiang, China

RECRUITING

Taizhou Enze Medical Center Group

Zhejiang, China

RECRUITING

Zhuji People's Hospital of Zhejiang Province

Zhejiang, China

NOT YET RECRUITING

MeSH Terms

Interventions

Indomethacin

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Liang-Hao Hu

CONTACT

+8613817593520; lianghao-hu@hotmail.com

Zhao-Shen Li

CONTACT

zhaoshen-li@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 19, 2025
• First Posted: July 28, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

CN (12)