Actively Recruiting
Low-Dose vs Standard-Dose Indomethacin for Preventing Post-ERCP Pancreatitis
Led by Changhai Hospital · Updated on 2025-11-18
1366
Participants Needed
12
Research Sites
63 weeks
Total Duration
On this page
Sponsors
C
Changhai Hospital
Lead Sponsor
S
Sir Run Run Shaw Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Low-Dose vs Standard-Dose Indomethacin for Preventing Post-ERCP Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Patients planned to undergo Endoscopic Retrograde Cholangiopancreatography
You will not qualify if you...
- 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 due to gastrointestinal hemorrhage within 4 weeks, renal dysfunction (Creatinine >1.4mg/dl=120umol/l), or 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 12 locations
1
Changhai Hospital
Shanghai, China
Not Yet Recruiting
2
Ruijin Hospital
Shanghai, China
Actively Recruiting
3
Shanghai General Hospital
Shanghai, China
Not Yet Recruiting
4
Affiliated Hospital of Jiaxing University
Zhejiang, China
Not Yet Recruiting
5
Dongyang People's Hospital
Zhejiang, China
Not Yet Recruiting
6
First Affiliated Hospital of Ningbo University
Zhejiang, China
Not Yet Recruiting
7
Jinhua Central Hospital
Zhejiang, China
Not Yet Recruiting
8
People's Hospital of Quzhou
Zhejiang, China
Not Yet Recruiting
9
Shaoxing People's Hospital
Zhejiang, China
Not Yet Recruiting
10
Sir Run Run Shaw Hospital
Zhejiang, China
Actively Recruiting
11
Taizhou Enze Medical Center Group
Zhejiang, China
Actively Recruiting
12
Zhuji People's Hospital of Zhejiang Province
Zhejiang, China
Not Yet Recruiting
Research Team
L
Liang-Hao Hu
CONTACT
Z
Zhao-Shen Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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