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Management for Concomitant Gallstones and Common Bile Duct Stones.

NCT04758923 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-09-04

No results posted yet for this study

Summary

Choledocholithiasis is identified in approximately 3-10 % of patients with cholelithiasis. (1-3) While laparoscopic cholecystectomy (LC) is considered the treatment of choice in patients with gall bladder stones, there is a debate about the management of common bile duct (CBD) stones, (4) and this has led to a range of therapeutic strategies for the management of concomitant gallstones and CBD stones patients. Two-stage endoscopic management using endoscopic retrograde cholangiopancreatography (ERCP) followed by laparoscopic cholecystectomy is a common approach, although single-stage management by laparoscopic cholecystectomy with surgical exploration of the CBD is an alternative, with the single-stage approach more common in the open surgery era. Currently, it is unclear whether two-stage management is better than or at least equivalent to the single-stage surgical approach to choledocholithiasis. To address this, we undertook this study to compare these two approaches. The aim of this prospective randomized trial was to determine the best technique for the management of patients with concomitant gallstones and common bile duct stones, by comparing the success rate, complication rates, and longer-term follow-up outcomes.

Conditions

  • Calculus Biliary

Interventions

PROCEDURE

Cholecystectomy

Under General anaesthesia cholecystectomy and CBD exploration

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2026-09-01
Completion
2026-09-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04758923 on ClinicalTrials.gov