Comparison of two bile duct cannulation methods in difficult ERCP cases

Comparison of two preincisional sphincterotomy methods, needle knife fistulotomy versus transpancreatic sphincterotomy as path-breaking treatments in difficult ERCP conditions: a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220905055884N1

Enrollment

128

Registered

2022-10-05

Start date

2022-03-21

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Obstruction of bile duct. Obstruction of bile duct

Interventions

Intervention 1: Intervention group: Patients who underwent fistulotomy with a needle knife above the papillary opening and then bile duct cannulation. Intervention 2: Intervention group: Patients unde

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: People more than 18 years old Patients with acute pancreatitis (elevation of Amylase and Lipase more than 3-fold the upper limit of normal) suspicious of Acute biliary pancreatitis Patients with gallstone in ultrasound suspicious of CBD stone (symptomatic gallstone disease) Biochemical (elevation of AST, ALT, ALP and/or bilirubin) and ultrasound findings (stone detection and/or CBD dilation) indicating CBD stone or CBD obstruction

Exclusion criteria

Exclusion criteria: Patients with severe coagulopathy or previous gastric surgery with Roux_en_y Gastrojejunostomy Pregnancy Sensitivity to contrast material Sensitivity to contrast material

Design outcomes

Primary

Measure	Time frame
Temperature. Timepoint: Before and after the procedure. Method of measurement: Body temperature measuring tool.;Complete blood count (CBC) differentiation. Timepoint: Before and after the procedure. Method of measurement: Blood test.;Amylas. Timepoint: Before and after the procedure. Method of measurement: Blood test.;Lipase. Timepoint: Before and after the procedure. Method of measurement: Blood test.;Post ERCP bleeding. Timepoint: During or after the procedure. Method of measurement: Clinical evidence of bleeding with hemoglobin drop.;Post ERCP Pancreatitis. Timepoint: 6 hours after the procedure. Method of measurement: Amylase at least 3 times normal more than 24 hours after the procedure with abdominal pain.;Post ERCP Perforation. 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 ERCP. Method of measurement: When the bile duct become infected(RUQ pain, T>38).	—

Measure

Time frame

Temperature. Timepoint: Before and after the procedure. Method of measurement: Body temperature measuring tool.;Complete blood count (CBC) differentiation. Timepoint: Before and after the procedure. Method of measurement: Blood test.;Amylas. Timepoint: Before and after the procedure. Method of measurement: Blood test.;Lipase. Timepoint: Before and after the procedure. Method of measurement: Blood test.;Post ERCP bleeding. Timepoint: During or after the procedure. Method of measurement: Clinical evidence of bleeding with hemoglobin drop.;Post ERCP Pancreatitis. Timepoint: 6 hours after the procedure. Method of measurement: Amylase at least 3 times normal more than 24 hours after the procedure with abdominal pain.;Post ERCP Perforation. 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 ERCP. Method of measurement: When the bile duct become infected(RUQ pain, T>38).

—

Secondary

Measure	Time frame
. Timepoint: . Method of measurement: .	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzam Farahani

Shahid Beheshti University of Medical Sciences

drfarahanie@gmail.com+98 21 2243 2524

Outcome results

None listed

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