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

Investigation of the efficacy of prophylactic pancreatic duct stenting in the prevention of post-ERCP-pancreatitis in patients with difficult common bile duct cannulation using double guide wire technique

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230314057717N3

Enrollment

238

Registered

2023-07-05

Start date

2023-07-23

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

Bile duct disease. Obstruction of bile duct

Interventions

Intervention 1: Intervention group: Patients who undergo implantation of a 5cm-5Fr pigtail Boston Scientific stent in the pancreatic duct. Intervention 2: Control group: Patients who do not undergo bi

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Secondary

Measure	Time frame
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.	—

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactGholamreza Noori

Shahid Beheshti University of Medical Sciences

dr_noori11@yahoo.com+98 21 2243 2540

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026