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

Not yet recruiting

• Conditions: Common Bile Duct Calculi
• Interventions: Device: laparoscopy

• Registration Number: NCT05823181
• Lead Sponsor: Assiut University

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 .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-25
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-09
• Last Update Submitted: 2023-04-09
• Study First Posted: 2023-04-21
• Last Update Posted: 2023-04-21
• Study Start: 2023-09-01
• Primary Completion: 2025-09
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Early laparoscopic exploration of common bile duct	laparoscopy	Early laparoscopic exploration of common bile duct after failure of extraction of common bile duct stones by ERCP
Late laparoscopic exploration of common bile duct	laparoscopy	late laparoscopic exploration of common bile duct after failure of extraction of common bile duct stones by ERCP

Primary Outcome Measures

Name	Time	Method
intraoperative complications	Baseline	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)

Secondary Outcome Measures

Name	Time	Method
postoperative complications	Baseline	1. Postoperative bleeding in millilitres; 2. biliary leakage in millilitres; 3. missed stone (yes or no); 4. 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.