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

NCT05823181 | Unknown

• 1 other identifier: CBD stone
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Common Bile Duct Calculi

Outcome Measures

Primary Outcomes (1)

• intraoperative complications

  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 Outcomes (1)

• postoperative complications

  Baseline

Study Arms (2)

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

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

Interventions

laparoscopy DEVICE

laparoscopic exploration of common bile duct

Early laparoscopic exploration of common bile duct; Late laparoscopic exploration of common bile duct

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Gallstones

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Ebram Abdelmalak Abd Awad, Resident dr

CONTACT

01208032279; ebrammalak195@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 25, 2023
• First Posted: April 21, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 21, 2023

Record last verified: 2023-04