Endoscopic balloon dilation alone with endoscopic sphinctrotomy alone

Evaluation of the efficacy of endoscopic balloon dilation alone with endoscopic sphinctrotomy alone in excluding common bile duct stone

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250527065934N1

Enrollment

Registered

2025-06-12

Start date

2025-06-10

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Choledocholithiasis. Calculus of bile duct without cholangitis or cholecystitis

Interventions

Intervention 1: Intervention Group: In the "endoscopic balloon dilation alone" group, after cannulation of the common bile duct (CBD) with a catheter, a balloon catheter (diameter 10 to 15 mm) is adva

the size is individually determined based on the indication for sphincter

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 80 years Confirmed diagnosis of CBD stones by ultrasound or MRCP Ability to provide written informed consent

Exclusion criteria

Exclusion criteria: A history of anaphylaxis to contrast media Severe cardiopulmonary disease Recent myocardial infarction History of sphincterotomy or balloon dilation Presence of pancreatobiliary malignancies Presence of biliary stricture Presence of intrahepatic stones Presence of acute cholecystitis Presence of acute pancreatitis Presence of acute cholangitis

Design outcomes

Primary

Measure	Time frame
Complete stone removal in one session. Timepoint: At the end of the endoscopic procedure. Method of measurement: By direct visualization at the end of the endoscopic procedure.;Complete stone removal. Timepoint: At the end of the final endoscopic procedure. Method of measurement: By direct visualization at the end of the final endoscopic procedure.	—

Secondary

Measure	Time frame
Procedure duration. Timepoint: At the end of the endoscopic procedure. Method of measurement: By direct visualization at the end of the endoscopic procedure.;Length of hospital stay. Timepoint: At the time of hospital discharge. Method of measurement: Based on medical records.;Post-ERCP complications. Timepoint: during the procedure and throughout the hospital stay. Method of measurement: Through direct observation by the physician during the endoscopy and monitoring of the patient's condition throughout the hospital stay.	—

Measure

Time frame

Procedure duration. Timepoint: At the end of the endoscopic procedure. Method of measurement: By direct visualization at the end of the endoscopic procedure.;Length of hospital stay. Timepoint: At the time of hospital discharge. Method of measurement: Based on medical records.;Post-ERCP complications. Timepoint: during the procedure and throughout the hospital stay. Method of measurement: Through direct observation by the physician during the endoscopy and monitoring of the patient's condition throughout the hospital stay.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Salehi

Ghoum University of Medical Sciences

mosalehi@muq.ac.ir0098 22712937

Outcome results

None listed

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