Oral indomethacin for the prevention of post-ERCP pancreatitis: A Randomized Controlled Trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20190218006

Enrollment

350

Registered

2019-02-18

Start date

2019-02-17

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post&#45

Interventions

guided cannulation with a sphincterotome. If cannulation failed&#44

precut sphincterotomy or the double&#45

wire technique was performed when appropriate. Therapeutic manipulation (e.g.&#44

sphincterotomy&#44

balloon dilation&#44

stone extraction&#44

and stenting) was done when appropriate. Pancreatic duct stent placement was performed at the discretion of the endoscopists. In case of trainee involvement in ERCP&#44

3 times of wired&#45

guide cannulation with a sphincterotome was acceptance.,Subjects were assigned randomly in a 1:1 ratio to groups given either a single 100&#45

Subjects were assigned randomly in a 1:1 ratio to groups given either a single 100&#45

mg dose of oral indomethacin or placebo at least 2 h before the procedure. All patients underwent ERCP with side&#45

view duodenoscope under conscious sedation or general anesthesia by experienced endoscopists who performed this procedure over 200 cases. Briefly&#44

all patients initially received wire&#45

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Patient (aged 18-85 years) with naÃ¯ve papilla planned for diagnostic or therapeutic ERCP were eligible for enrollment in the study

Exclusion criteria

Exclusion criteria: contraindication to ERCP, allergy to NSAIDs, contraindication to NSAIDs (including gastrointestinal hemorrhage within 4 weeks or renal dysfunction with serum creatinine > 1.4 mg/dl), previous biliary sphincterotomy, active pancreatitis, previous post-ERCP pancreatitis, active cardiovascular or cerebrovascular disease, unwilling or inability to provide consent and pregnant or breastfeeding women.

Design outcomes

Primary

Measure	Time frame
The incidence of post-ERCP pancreatitis 30 days Clinical follow-up and blood test	—

Secondary

Measure	Time frame
Adverse events of oral indomethacin administration 1 year Number of events	—

Countries

Thailand

Contacts

Public ContactWorrawat Sangwipasnapaporn

Division of Gastroenterology and Hepatology, Department of Medicine, Phramongkutklao hospital

wan6207@hotmail.com0815716207

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026

Oral indomethacin for the prevention of post&#45;ERCP pancreatitis: A Randomized Controlled Trial