Single-stage ERCP and Laparoscopic Cholecystectomy for Cholecystocholedocholithiasis: Which to Start With?

March 30, 2024 updated by: Mohamad Raafat, Assiut University

Single-stage Endoscopic Retrograde Cholangiopancreatography and Laparoscopic Cholecystectomy for Cholecystocholedocholithiasis: Which to Start With?

Chronic calculous cholecystitis is associated with common bile duct (CBD) stones in approximately 12% of patients. These patients need both cholecystectomy and CBD clearance of stones. The standard for cholecystectomy is laparoscopic cholecystectomy (LC) and the mostly common treatment used for CBD clearance is Endoscopic Retrograde Cholangiopancreatography (ERCP). The two interventions can be combined to be done at the same time under single anesthesia session. Studies of single stage ERCP+LC showed confirmed the safety and efficacy of the combined technique. However, some surgeons start with the ERCP while others start with LC.The aim of this study is to compare the start with ERCP followed by LC to the start with LC followed by ERCP when the two techniques are combined at the same session for treatment of chronic calculous cholecystitis associated with CBD stones regarding efficacy and safety of the two approaches.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

115

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

  • Egypt
    • Asyut
      • Assiut, Asyut, Egypt, 71515
        • Faculty of Medicine-Assiut University -Assiut-Egypt

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

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic calculous cholecystitis associated with common bile duct (CBD) stones admitted in a tertiary care hospital

Description

Inclusion Criteria:

  • Patients underwent single stage ERCP+LC for cholecystocholedocholithiasis

Exclusion Criteria:

  • Contraindications to ERCP, or laparoscopic surgery
  • Cholangitis and pancreatitis
  • Previously failed ERCP

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
Group A (ERCP 1st approach)
The patients first underwent ERCP followed by standard 4 port LC.
Procedure: Laproscopic cholecystectomy (LC)
Removal of gallbladder via laparoscopy
Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)
Removal of bile duct stones via endoscopy
Group B (LC 1st approach)
The patients first underwent LC followed by ERCP.
Procedure: Laproscopic cholecystectomy (LC)
Removal of gallbladder via laparoscopy
Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)
Removal of bile duct stones via endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time operative time
Time Frame: time in minutes from intubation of the patient to the end of procedure
total operative time of both ERCP+LC
time in minutes from intubation of the patient to the end of procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CBD clearance rate
Time Frame: up to 2 years
success rate of retrieval of stones
up to 2 years
Length of hospital stay
Time Frame: up to 2 weeks post-operative
days of hospital stay
up to 2 weeks post-operative
Mortality rate
Time Frame: up to 1 month postoperative
number of deaths intraoperative and postoperative related to surgery
up to 1 month postoperative

Collaborators and Investigators

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

Sponsor

Assiut 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)

January 1, 2021

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

January 30, 2024

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

April 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 30, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RF-2-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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