Investigating the effect of pancreatic duct stent in the prevention of pancreatitis after ERCP

Not Applicable

Recruiting

Conditions: Bile duct disease.
Obstruction of bile duct
K83.1

Registration Number: IRCT20230314057717N3

Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 238

Inclusion Criteria

Patients with acute pancreatitis (increased amylase and lipase 3 times more than normal)
Patients with gallstones on ultrasound suspected to have CBD stones (symptomatic gallstone disease)
Biochemical findings (increased AST, ALP, ALT or bilirubin)
Ultrasound findings (diagnosis of stones or enlargement of the CBD) that indicate a CBD stone or blockage of the CBD

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of pancreatitis after ERCP. Timepoint: 6 hours after the procedure. Method of measurement: Blood Amylase and/or lipase 3 times higher than normal 24 hours after the procedure with abdominal pain.;Success rate of bile duct cannulation. Timepoint: At the time of cannulation by the endoscopist. Method of measurement: Visual diagnosis of the endoscopist by observing the cannulation process on the monitor.;Bleeding. Timepoint: During or after the procedure. Method of measurement: Clinical evidence of bleeding or hemoglobin drop.;Perforation of bile duct. Timepoint: During the procedure. Method of measurement: Clinical evidence of perforation of the lateral or medial wall of the bile duct.;Cholangitis. Timepoint: 6 hours after the procedure. Method of measurement: When the bile duct becomes infected (abdominal pain and fever over 38 degrees).

Secondary Outcome Measures

Name	Time	Method
Body temperature. Timepoint: 4 hours after the completion of the procedure. Method of measurement: Thermometer.;Amylas. Timepoint: before the procedure and 3 hours after the procedure. Method of measurement: Blood test.;Lipas. Timepoint: before the procedure and 3 hours after the procedure. Method of measurement: Blood test.