Review of the least complicated technique of bile duct cannulation in difficult ERCP cases

Comparison of two technical methods of fistulotomy over a pancreatic guide-wire and trans-pancreatic sphincterotomy in difficult cases of ERCP with advertent or inadvertent PD cannulation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230314057717N1

Enrollment

200

Registered

2023-04-15

Start date

2023-04-21

Completion date

Unknown

Last updated

2023-05-01

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

Conditions

Obstruction of the bile ducts. Obstruction of bile duct

Interventions

Intervention 1: Intervention group: In the first group, the bile duct of the patients will be cannulated with the fistulotomy over the pancreatic guidewire technique. Patients will undergo ERCP in one

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: Patients with severe coagulopathy or previous Roux-en-y gastric surgery Gastrogenostomy pregnancy Contrast sensitivity History of previous sphincterotomy

Design outcomes

Primary

Measure	Time frame
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.;Pancreatic. Timepoint: 6 hours after the procedure. Method of measurement: Amylase and/or lipase 3 times higher than normal 24 hours after the procedure with abdominal pain.;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

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.;Pancreatic. Timepoint: 6 hours after the procedure. Method of measurement: Amylase and/or lipase 3 times higher than normal 24 hours after the procedure with abdominal pain.;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

Measure	Time frame
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 (CBC).;Lipas. Timepoint: before the procedure and 3 hours after the procedure. Method of measurement: blood test (CBC).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactEhsan Hosein zadeh

Shahid Beheshti University of Medical Sciences

hosseinzadehehsan@yahoo.com+98 21 2243 2540

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026