Management for Concomitant Gallstones and Common Bile Duct Stones.

Single-stage Versus Two-staged Management for Concomitant Gallstones and Common Bile Duct Stones

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Calculus Biliary
• Intervention / Treatment: Procedure: Cholecystectomy

Detailed Description

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 CBDand the CBD will be opened longitudinally for adistance of approximately 1to1.5 cm using laparoscopic scissors. A5mm flexible choledoscope will be used to identify the CBD stone(s) which will be removed by flushing sterile saline, passingastone basket, or electrohydraulic lithotrpsy as necessary 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. Cholangiography throuh T-tube be performed 14 14 days later and the T-tube will be removed immediately after Cholangiography if no residual CBD stones is identified. If residual stones are found then will be removed through the T-tube track using A choledoscope Two-stage approach The treatment process commenced with intial endoscopic treatment phase. This will be udertaken Under General anaesthesia and entailed ERCP and endoscopic sphincterectomy. The CBD stones will be removed using a basket or ballon, with lithotrpsy added if necessary. An endoscopic nasobiliary drainge will be inserted and kept in place until after laparoscopic cholecystectomy which perfermed 2 to 5 days later depending on the patients 's condition.. Surgery will be delsyed if urine amylase is elevated or significant abdominal pain is present. 2 to 5 days after the operation, Cholangiography will be performed via endoscopic nasobiliary drainge tube. And the endoscopic nasobiliary drainge tube wii be removed if no residual CBD stones are seen.

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Two-Stage; 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; Under General anaesthesia cholecystectomy and CBD exploration
Active Comparator: Single stage; 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; Under General anaesthesia cholecystectomy and CBD exploration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2023
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: September 20, 2020
• First Submitted That Met QC Criteria: February 13, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 13, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Cholelithiasis; Cholecystolithiasis; Calculi; Gallstones
• Other Study ID Numbers: Assuit university hospital..

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No