NCT05901363

Brief Summary

Around 10-18% of patients undergoing cholecystectomy for gallstones have common bile duct (CBD) stones. Currently, various procedures for the treatment of cholecystocholedocholithiasis are available including open cholecystectomy plus open common bile duct exploration (OC+OCBDE), laparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC+LCBDE), may be trans-cystic or trans-choledochal, and laparoscopic cholecystectomy plus endoscopic retrograde cholangiopancreatography (LC+ERCP), which may be performed pre, at, or after LC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
218

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

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

February 1, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 13, 2023

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

2.7 years

First QC Date

June 3, 2023

Last Update Submit

June 12, 2023

Conditions

Common Bile Duct Calculi

Keywords

Endoscopic retrograde cholangiopancreatographylaparoscopic common bile duct explorationLaparoscopic cholecystectomysingle operatorcholecystocholedocholithiasis

Outcome Measures

Primary Outcomes (1)

  • success rate

    successful laparoscopic cholecystectomy and successful common bile duct stone extraction

    2 years

Secondary Outcomes (7)

  • operative time

    from 1 to 5 hours

  • morbidity

    3 years

  • mortality

    3 years

  • Hospital stay

    30 days

  • the number of hospital readmission

    3 years

  • +2 more secondary outcomes

Study Arms (2)

Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy

EXPERIMENTAL

endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy

Procedure: Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy

laparoscopic common bile duct exploration and laparoscopic cholecystectomy

ACTIVE COMPARATOR
Procedure: aparoscopic common bile duct exploration and laparoscopic cholecystectomy

Interventions

Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomyPROCEDURE

laparoscopic removal of gallbladder and endoscopic extraction of common bile duct stones

Also known as: ERCP plus LC
Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy
aparoscopic common bile duct exploration and laparoscopic cholecystectomyPROCEDURE

laparoscopic removal of gallbladder and laparoscopic extraction of common bile duct stones

Also known as: LCBDE plus LC
laparoscopic common bile duct exploration and laparoscopic cholecystectomy

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with cholecystocholedocholithiasis
  • American Society of Anesthesiologists (ASA) scores of I-III
  • Age 20-70 years.

You may not qualify if:

  • cholangitis,
  • acute biliary pancreatitis,
  • suspected Mirizzi syndrome,
  • suspected hepatobiliary malignancy,
  • perforated gallbladder,
  • biliary peritonitis,
  • intrahepatic stones,
  • pregnancy,
  • previous cholecystectomy,
  • altered anatomy such as Billroth II reconstruction or any form of Roux-en-Y reconstruction that interfere with the endoscopic approach,
  • Contraindications to laparoscopic surgery as severe liver cirrhosis or upper abdominal surgery were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohammed Ahmed Omar

Qina, Qena Governorate, 83523, Egypt

Location

MeSH Terms

Conditions

Gallstones

Interventions

Cholangiopancreatography, Endoscopic RetrogradeCholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CholangiographyRadiography, AbdominalRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Digestive SystemEndoscopy, Digestive SystemEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresCholecystectomyBiliary Tract Surgical ProceduresLaparoscopy

Study Officials

  • Mohammed A Omar

    General Surgery Department, Faculty of Medicine, South Valley University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of surgery

Study Record Dates

First Submitted

June 3, 2023

First Posted

June 13, 2023

Study Start

February 1, 2019

Primary Completion

October 30, 2021

Study Completion

October 30, 2022

Last Updated

June 13, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

After publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
For 1 year
Access Criteria
After publication

Locations

EG(1)