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

Common Bile Duct Calculi Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05823181
• Other study ID #: CBD stone
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: November 2025

Study information

• Verified date: April 2023
• Source: Assiut University
• Contact: Ebram Abdelmalak Abd Awad, Resident dr
• Phone: 01208032279
• Email: ebrammalak195[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Calculi
• Common Bile Duct Calculi
• Gallstones

Intervention

Device:
• laparoscopy
laparoscopic exploration of common bile duct

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraoperative complications	Assess the operative time in hours; intraoperative blood loss in millilitres; intraoperative organ injury (yes or no); conversion to open surgery (yes or no)	Baseline
Secondary	postoperative complications	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.	Baseline