Management for Concomitant Gallstones and Common Bile Duct Stones.

NCT04758923 | Not Yet Recruiting DMC

• 1 other identifier: Assuit university hospital..
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Surgical successful rates

  The prospective clinical trial aims to determine the best technigue for the management of the patient with concomitant GB and CBD stones by comparing success rate and complication rates

  2 weeks

Study Arms (2)

Two-Stage

ACTIVE COMPARATOR

Two-stage approach The treatment process commenced with an intial treatment phase. This will be udertaken Under General anaesthesia and entailed ERCP and endoscopic sphincterectomy

Procedure: Cholecystectomy

Single stage

ACTIVE COMPARATOR

Single stage approach Under General anaesthesia a5 trocar method will be used to access the abdominal cavity. Aconventional approach to laparoscopic cholecystectomy will be first udertaken with dissection of calot's triangle. The cystic duct will be pulled laterally to facilitate exposure of the anterior wall of the CBD, and the CBD will be opened longitudinally for a distance of approximately 1 to 1.5 cm using laparoscopic scissors. A5 mm flexible choledoscope will be used to identify the cbd stone which will be removed by flushing with sterile saline, passing a stone basket or electrohydroulic lithotripsy as neccesary to clear the CBD. A T-tube will be inserted into the CBD via the choledochotomy which will be closed by interrupted resorbable sutures before completing the cholecystectomy.

Procedure: Cholecystectomy

Interventions

Cholecystectomy PROCEDURE

Under General anaesthesia cholecystectomy and CBD exploration

Single stage; Two-Stage

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 16 to 70 years; Clinical presentation with biliary colic with or without jaundice; Serum elevation of at least one of the following enzymes: aspartate aminotransferase, alanine aminotransferase, glutamyl transpeptidase, alkaline phosphatase, and total bilirubin; Radiological findings suggestive of gallstones and concomitant common bile duct stones, with abdominal ultrasound showing possible CBD stones or a dilated CBD \>8 mm in diameter.
• only patients with MRCP evidence of a CBD stone(s) were eligible after meeting all the previous criteria.

You may not qualify if:

• active acute pancreatitis, pregnancy, septic shock, intrahepatic gallstones, malignant pancreatic or biliary tumors, prior sphincterotomy, unfit for anesthesia and surgery, contraindications to MRCP and ERCP, liver cirrhosis, previous history of abdominal surgery (e.g., gastrectomy), and inability to give informed consent.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Cholecystolithiasis

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 20, 2020
• First Posted: February 17, 2021
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share