ERCP Management in Mild Gallstone-Induced Pancreatitis Patients Declining Subsequent Cholecystectomy : a Randomized Control Trial.

to investigate the role and potential benefits or drawbacks of ERCP with sphincterotomy in patients declining subsequent cholecystectomy for gallstone-induced pancreatitis.

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Key information

Conditions

Pancreatitis Digestive System Diseases Pancreatic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of gallstone-related pancreatitis (classified as mild pancreatitis according to the 2012 revised Atlanta classification and definitions).

Imaging studies reveal the presence of gallstones or sludge, along with at least one of the following conditions: i. Imaging evidence of common bile duct dilation (common bile duct diameter > 8 mm for patients aged ≤ 75 years; > 10 mm for patients aged > 75 years).

ii. Biochemical evidence of cholestasis with total bilirubin levels between 1.8 - 4 mg/dL.

iii. Alanine aminotransferase (ALT) levels greater than twice the upper limit of normal.

Treatment and study plan

ERCP

Procedure

ERPC endoscopic sphictotomy

Primary outcomes

recurrent pancreatitis

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Fu Jen Catholic University Hospital

Other

Registry information

Official study title

Comparison of Endoscopic Sphincterotomy and Conservative Management in Mild Gallstone-Induced Pancreatitis Patients Declining Subsequent Cholecystectomy : a Randomized Control Trial.

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Mar 6, 2026
Registry last updated: Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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