Post-ERCP Pancreatitis
Conditions
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.
Interventions
Patients randomized to this intervention receive 100mg indomethacin suppositories within 30 min before ERCP.
DRUGlow dose indomethacin
Patients randomized to this intervention receive 50mg indomethacin suppositories within 30 min before ERCP.
Sponsors
Sir Run Run Shaw Hospital
Ruijin Hospital
Shanghai General Hospital, China
Jinhua Central Hospital
Taizhou Enze Medical Center Group
Dongyang People's Hospital
Shaoxing People's Hospital
First Affiliated Hospital of Ningbo University
Affiliated Hospital of Jiaxing University
People's Hospital of Quzhou
Zhuji People's Hospital of Zhejiang Province
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older. * Patients planned to undergo Endoscopic Retrograde Cholangiopancreatography
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Proportion of Subjects in Each Study Group With Post-ERCP Pancreatitis | Within 48 hours after ERCP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Overall ERCP-related complications | Within one month of ERCP | ERCP-related complications include post-ERCP pancreatitis, gastrointestinal bleeding, perforation or infection according to Cotton Criteria. |
| Rate of ERCP-related perforation | Within one month of ERCP | — |
| The Proportion of Subjects in Each Study Group With Moderate-severe Post-ERCP Pancreatitis | Within one month of ERCP | — |
| Rate of ERCP-related bleeding | Within one month of ERCP | — |
| Rate of NSAIDs-related complications | Within one month of ERCP | NSAIDs-related complications include: acute kidney injury, allergic reaction, gastrointestinal bleeding, myocardial infarction, cerebrovascular accident, and death |
| Rate of ERCP-related infection | Within one month of ERCP | — |
Countries
China
Contacts
Primary ContactLiang-Hao Hu
Backup ContactZhao-Shen Li
Outcome results
None listed