NCT06349876

Brief Summary

Aim of this study is to evaluate the efficacy of performing only cholecystectomy in patients with asymptomatic common bile duct stones without dealing with common bile duct stones

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

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 15, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2024

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

March 31, 2024

Last Update Submit

April 19, 2024

Conditions

Performing Cholecystectomy in Patients With Chronic Calcular Choleycystits

Keywords

CBD stones ,cholecystectomysilent stones

Outcome Measures

Primary Outcomes (1)

  • number of patients developed jaundice post cholecystectomy

    patients presented by symptomatic gall bladder stones and during investigation discovered that they have silent common bile duct stone so we assess the safety of performing cholecystectomy without developing jaundice

    6 months

Study Arms (1)

lap chole

patients presented by cholecystitis with silent CBD stones

Procedure: laparoscopic cholecystectomy

Interventions

laparoscopic cholecystectomyPROCEDURE

slandered laparoscopic cholecystectomy

lap chole

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

patients presented by chronic calcular cholecystitis and during investigation they discovers that they have silent common bile duct stones

You may qualify if:

  • Patients with asymptomatic common bile duct stones.
  • Patients with normal bilirubin levels.
  • Patients with normal alkaline phosphates level.

You may not qualify if:

  • Patients with history of jaundice.
  • Patients with abnormal liver functions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Qeft Teatching Hospital

Qina, Egypt

Location

Qena Faculty of Medicine

Qina, Egypt

Location

Suez Faculty of Medicine

Suez, 43221, Egypt

Location

Related Publications (1)

  • Maklad AA, Eltantawy M, Siam M, Abdelshafy M. Feasibility of cholecystectomy in patients with silent common bile duct stones cohort prospective single arm multicentre study. BMC Gastroenterol. 2025 Mar 11;25(1):158. doi: 10.1186/s12876-024-03459-6.

    PMID: 40069599DERIVED

MeSH Terms

Interventions

Cholecystectomy, Laparoscopic

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

March 31, 2024

First Posted

April 5, 2024

Study Start

February 15, 2023

Primary Completion

July 15, 2023

Study Completion

January 15, 2024

Last Updated

April 23, 2024

Record last verified: 2024-04

Locations

EG(3)