Laparoscopic Cholodochotomy in Management of CBD Stones

June 12, 2025 updated by: Islam Khalaf Mohamed, Sohag University

Primary Closure Versus T-tube Drainage Following Laparoscopic Cholodochotomy in Management of CBD Stones

The aim of this study is to compare the outcomes of primary closure of cholodochotomy incision versus T-tube drainage in laparoscopic common bile duct exploration for management of CBD stones and provide evidence-based guidance to the selection of the most appropriate operative technique.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: alaa el-din H Mohamed, Professor
  • Phone Number: 01069227827

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin, professor

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. patients with a definitive preoperative diagnosed with CBD stones.
  2. a CBD diameter of ≥1 cm.
  3. patients are fit for surgery

Exclusion Criteria:

  1. patients with liver cirrhosis.
  2. a CBD diameter of <1 cm
  3. malignancy in the biliary tract or CBD stricture .
  4. patients are not fit for surgery.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: primary closure following Laparoscopic cholodochotomy in management of CBD stones
Procedure: primary closure following Laparoscopic cholodochotomy in management of CBD stones
primary closure of cholodochotomy incision in laparoscopic CBD exploration avoiding T-tube insertion
Active Comparator: T-tube drainage following Laparoscopic cholodochotomy in management of CBD stones
Procedure: T-tube drainage following Laparoscopic cholodochotomy in management of CBD stones
drainage of bile by T-tube insertion in laparpscopic CBD exploration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
biliary leakage in the management of CBD stones
Time Frame: 3 days after the operation
peritoneal collection of bile after common bile duct exploration
3 days after the operation

Collaborators and Investigators

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

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 10, 2024

Primary Completion (Estimated)

June 25, 2025

Study Completion (Estimated)

June 25, 2025

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

July 17, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

June 15, 2025

Last Update Submitted That Met QC Criteria

June 12, 2025

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-06-25MS

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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