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

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05823181

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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 .

Condition or Disease	Intervention/Treatment	Phase
Common Bile Duct Calculi	Device: laparoscopy

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Nov 1, 2025

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

intraoperative complications [Baseline]
Assess the operative time in hours intraoperative blood loss in millilitres intraoperative organ injury (yes or no) conversion to open surgery (yes or no)

Secondary Outcome Measures

postoperative complications [Baseline]
Postoperative bleeding in millilitres biliary leakage in millilitres missed stone (yes or no) 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ebram Abdelmalak Abd, Principal Investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT05823181

Other Study ID Numbers:

CBD stone

First Posted:

Apr 21, 2023

Last Update Posted:

Apr 21, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gallstones

Calculi

Study Results

No Results Posted as of Apr 21, 2023