NCT07455227Not yet recruitingNot Applicable
Comparison of Endoscopic Sphincterotomy and Conservative Management in Mild Gallstone-Induced Pancreatitis Patients Declining Subsequent Cholecystectomy : a Randomized Control Trial.
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 30
- Primary Endpoint
- recurrent pancreatitis
Study Overview
Brief Summary
to investigate the role and potential benefits or drawbacks of ERCP with sphincterotomy in patients declining subsequent cholecystectomy for gallstone-induced pancreatitis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
No Intervention
ERCP
Experimental
Intervention: ERCP (Procedure)
Outcomes
Primary Outcomes
recurrent pancreatitis
Time Frame: 1 year
Secondary Outcomes
No secondary outcomes reported
Investigators
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