Early Versus Late Laparoscopic Exploration of Common Bile Duct After Failure of Extraction of Common Bile Duct Stones by ERCP

April 9, 2023 updated by: Ebram Abdelmalak Abd, Assiut University
The goal of this work is to assess the best time to perform LC combined with LCBD exploration and the feasibility and safety of such procedure in patients with combined GBS and CBDS after failure of ERCP extraction of CBD stones .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

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

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

Sampling Method

Non-Probability Sample

Study Population

All patients that presented with calcular obstructive jaundice 2ry to CBD stones and failed of extraction of common bile duct stone by ERCP.

Description

Inclusion Criteria:

  1. All patients that presented with calcular obstructive jaundice 2ry to CBD stones.
  2. Failed of extraction of common bile duct stone by ERCP.

Exclusion Criteria:

  1. patients presented by cholangitis.
  2. patients presented by acute pancreatitis.
  3. Patients that developed post ERCP pancreatitis ,bleeding , perforation.
  4. history of previous biliary surgery rather than cholecystectomy.
  5. history of major upper abdominal surgery.
  6. pregnant females.
  7. patients with liverchirosis, abdominal malignancy , and those unfit 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Early laparoscopic exploration of common bile duct
Early laparoscopic exploration of common bile duct after failure of extraction of common bile duct stones by ERCP
Device: laparoscopy
laparoscopic exploration of common bile duct
Late laparoscopic exploration of common bile duct
late laparoscopic exploration of common bile duct after failure of extraction of common bile duct stones by ERCP
Device: laparoscopy
laparoscopic exploration of common bile duct

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative complications
Time Frame: Baseline
  1. Assess the operative time in hours
  2. intraoperative blood loss in millilitres
  3. intraoperative organ injury (yes or no)
  4. conversion to open surgery (yes or no)
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative complications
Time Frame: Baseline
  1. Postoperative bleeding in millilitres
  2. biliary leakage in millilitres
  3. missed stone (yes or no)
  4. recumbency complications which are monitored for 30 days postoperatively. 5.Overall length of hospital stay and if Intensive Care Unit (ICU) stay needed will also be recorded in days.
Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

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 (Anticipated)

September 1, 2023

Primary Completion (Anticipated)

September 1, 2025

Study Completion (Anticipated)

November 1, 2025

Study Registration Dates

First Submitted

February 25, 2023

First Submitted That Met QC Criteria

April 9, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 9, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBD stone

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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