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

March 22, 2026 updated by: North Estonia Medical Centre

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
    • Harju
      • Tallinn, Harju, Estonia, 13419
        • North Estonia Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time, 30-day post-operative complications, hospital length of stay
Time Frame: 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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Estonia Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Actual)

February 28, 2026

Study Completion (Actual)

February 28, 2026

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 22, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 22, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NorthEstoniaMC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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