NCT07490730

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

March 16, 2026

Last Update Submit

March 22, 2026

Conditions

Cholelithiasis

Keywords

Common bile duct stonesLaparoscopic cholecystectomyMRTEndoscopic balloon dilatation

Outcome Measures

Primary Outcomes (1)

  • Common bile duct clearance

    The clearance rate of common bile duct from stones confirmed by post-procedural Magnetic Resonance Cholangiopancreatography (MRCP)

    30 days

Secondary Outcomes (1)

  • Operative time, 30-day post-operative complications, hospital length of stay

    30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive adult patients with radiographically confirmed common bile duct stones eligible for emergency laparoscopic cholecystectomy

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Estonia Medical Centre

Tallinn, Harju, 13419, Estonia

Location

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 24, 2026

Study Start

May 1, 2025

Primary Completion

February 28, 2026

Study Completion

February 28, 2026

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations

ES(1)