Single-stage ERCP and Laparoscopic Cholecystectomy for Cholecystocholedocholithiasis: Which to Start With?

Completed

• Conditions: Choledocholithiasis With Cholecystitis; Biliary Stones
• Interventions: Procedure: Laproscopic cholecystectomy (LC); Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)

• Registration Number: NCT06340594
• Lead Sponsor: Assiut University

Brief Summary

Chronic calculous cholecystitis is associated with common bile duct (CBD) stones in approximately 12% of patients. These patients need both cholecystectomy and CBD clearance of stones. The standard for cholecystectomy is laparoscopic cholecystectomy (LC) and the mostly common treatment used for CBD clearance is Endoscopic Retrograde Cholangiopancreatography (ERCP). The two interventions can be combined to be done at the same time under single anesthesia session. Studies of single stage ERCP+LC showed confirmed the safety and efficacy of the combined technique. However, some surgeons start with the ERCP while others start with LC.The aim of this study is to compare the start with ERCP followed by LC to the start with LC followed by ERCP when the two techniques are combined at the same session for treatment of chronic calculous cholecystitis associated with CBD stones regarding efficacy and safety of the two approaches.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2023-12-01
• Study Completion: 2024-01-30
• Status Verified: 2024-03
• Study First Submitted: 2024-03-25
• Study First Submitted QC: 2024-03-25
• Last Update Submitted: 2024-03-30
• Study First Posted: 2024-04-01
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

• Patients underwent single stage ERCP+LC for cholecystocholedocholithiasis

Exclusion Criteria

• Contraindications to ERCP, or laparoscopic surgery
• Cholangitis and pancreatitis
• Previously failed ERCP

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B (LC 1st approach)	Endoscopic Retrograde Cholangiopancreatography (ERCP)	The patients first underwent LC followed by ERCP.
Group A (ERCP 1st approach)	Endoscopic Retrograde Cholangiopancreatography (ERCP)	The patients first underwent ERCP followed by standard 4 port LC.
Group A (ERCP 1st approach)	Laproscopic cholecystectomy (LC)	The patients first underwent ERCP followed by standard 4 port LC.
Group B (LC 1st approach)	Laproscopic cholecystectomy (LC)	The patients first underwent LC followed by ERCP.

Primary Outcome Measures

Name	Time	Method
Operative time operative time	time in minutes from intubation of the patient to the end of procedure	total operative time of both ERCP+LC

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	up to 2 weeks post-operative	days of hospital stay
Mortality rate	up to 1 month postoperative	number of deaths intraoperative and postoperative related to surgery
CBD clearance rate	up to 2 years	success rate of retrieval of stones

Trial Locations

Locations (1)

Faculty of Medicine-Assiut University -Assiut-Egypt; 🇪🇬 Assiut, Asyut, Egypt