Antegrade Transcystic Balloon Dilatation of the Papillary Sphincter During Emergency Laparoscopic Cholecystectomy for Common Bile Duct Stones

Antegrade Transcystic Balloon Dilatation of the Papillary Sphincter During Emergency Laparoscopic Cholecystectomy for Common Bile Duct Stones: A Prospective Validation Study With Postoperative MRCP Confirmation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07490730

Enrollment

100

Registered

2026-03-24

Start date

2025-05-01

Completion date

2026-02-28

Last updated

2026-03-24

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

Conditions

Cholelithiasis

Keywords

Common bile duct stones, Laparoscopic cholecystectomy, MRT, Endoscopic balloon dilatation

Brief summary

Adult patients diagnosed with common bile duct stones scheduled for laparoscopic cholecystectomy undergo intraoperative endoscopic sphincteric balloon dilatation (EBD). Postoperatively patients receive a MRT to confirm bile duct clearance. Patients are monitored for 30 day postoperative complications. EBD results are compared with those of ERCP that is more commonly used for bile duct clearance.

Detailed description

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Radiographically confirmed (ultrasonography, computed tomography, magnetic resonance cholangiopancreatography) stones in the common bile duct * Eligible for laparoscopic cholecystectomy * Understood and signed written consent form

Exclusion criteria

* Severe cholangitis (according to TOKYO2018 guidelines) * Severe pancreatitis (BISAP score of 3 or more) * Septic shock * Common bile duct stones larger than 15 mm

Design outcomes

Primary

Measure	Time frame	Description
Common bile duct clearance	30 days	The clearance rate of common bile duct from stones confirmed by post-procedural Magnetic Resonance Cholangiopancreatography (MRCP)

Secondary

Measure	Time frame	Description
Operative time, 30-day post-operative complications, hospital length of stay	30 days	The duration of the operation in minutes from incision to skin closure; post-operative complications that were registered within 30 days after the operation, patients' hospital length of stay in days

Countries

Estonia

Outcome results