Two Institutes Experience in Laparo-Endoscopic Rendezvous Technique for Gallbladder and Bile Duct Stones

Two Institutes Experience In Laparo-Endoscopic Rendezvous Technique For Patients Undergoing Laparscopic Cholecystectomy For Stones In The Gallbladder And Bile Duct; A Prospective Randomized Comparative Clinical Trial

The management of gallbladder stones (lithiasis) concomitant with bile duct stones is controversial. The management of CBD stones has evolved considerably since the advent of laparoscopic surgery. The more frequent approach is a two-stage procedure, with endoscopic sphincterotomy and stone removal from the bile duct followed by laparoscopic cholecystectomy. The laparoscopic-endoscopic rendezvous combines the two techniques in a single-stage operation. So the aim of this study was was to evaluate one-stage LC with intra-operative endoscopic sphincterotomy (IOES) vs two-stage pre-operative endoscopic sphincterotomy (POES) followed by LC for the treatment of cholecystocholedocholithiasis.

Study Overview

• Status: Completed
• Conditions: Calculus; Gallbladder, With Cholecystitis
• Intervention / Treatment: Procedure: The intraoperative ERCP has been performed immediately before LC; Procedure: POES followed by LC

Detailed Description

This is two center study was carried out on 523 patients and completed in 436 patients with gall bladder stones and with suspected or confirmed CBDS at two gastroenterology center at zagazig first 264 patients at the Gastrointestinal Surgery Unit in the Zagazig University Hospitals and second 172 patients at gastroenterology unite at AL AHRAR hospital from January 2010 till April 2022. A single-step technique combining LC and IO-ERCP was used to treat them. To confirm the presence of CBDS, a laparoscopic intraoperative cholangiography (IOC) was performed. A soft-tipped guidewire was inserted into the duodenum through the cystic duct and papilla. Over the guide-wire, an endoscopic papillotomy was introduced. The stones were retrieved with a retrieval balloon after an IO-ERCP and endoscopic sphincterotomy. The length of the postoperative hospital stay, surgical operating time, surgical success rate, postoperative complications, and residual CBDS were all evaluated. 77 patients excluded either incomplete data or didn't complete both steps within our centers.

• Study Type: Interventional
• Enrollment (Actual): 432
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. patients having stone in the gallbladder and concurrent CBD stone, as determined by MRCP or US.
2. Patients with acute cholecystitis, acute cholangitis, obstructive jaundice, and those with highly suspicious criteria for CBD, stones such as dilated CBD on US examination more than7 mm in diameter without obvious CBD stones, high serum bilirubin level, and or high serum alkaline phosphatase level, were also included in this study.

Exclusion Criteria:

1. Patients with history of hepatobiliary surgery as choledocho-duodenal anastomosis.
2. Patients with previous ERCP attempt.
3. Patients with previous upper abdominal surgery as total or partial gastric resection.
4. Patients with morbid obesity.
5. Patients with uncorrectable coagulopathy.
6. Patients aged below 18 years or above 80 years.
7. Patients within the American Society of Anesthesiology (ASA) class 4 and 5 disease.
8. Patients who refused to give consent or participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laparo-endoscopic "rendezvous" technique; the first group was treated by a single-step procedure combining LC and IOES	Procedure: The intraoperative ERCP has been performed immediately before LC; combination approach has been used to improve patient compliance and shorten hospital stays. The intraoperative ERCP has been performed immediately before Laparoscopic Cholecystectomy
Other: POES followed by LC; the second (control) group was treated by 2-stage (sequential treatment) POES followed by LC.	Procedure: POES followed by LC; Treatment in two stages, which combines a preoperative ES followed by LC (sequential treatment).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
successful stone clearance from the CBD	To ensure that the bile duct was completely clear, a check cholangiogram was conducted.	first year postoperatively

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Cholelithiasis; Cholecystitis; Calculi; Gallstones; Cholecystolithiasis
• Other Study ID Numbers: 10129/20-11-2022

Drug and device information, study documents

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