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

Zagazig University

Status: Completed

Conditions: Calculus; Gallbladder, With Cholecystitis

Treatments: Procedure: The intraoperative ERCP has been performed immediately before LC; Procedure: POES followed by LC

Study type: Interventional

Funder types: Other

Identifiers

NCT05734144

10129/20-11-2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 432 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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432 participants in 2 patient groups

Laparo-endoscopic "rendezvous" technique

Active Comparator group

Description:

the first group was treated by a single-step procedure combining LC and IOES

Treatment:

Procedure: The intraoperative ERCP has been performed immediately before LC

POES followed by LC

Other group

Description:

the second (control) group was treated by 2-stage (sequential treatment) POES followed by LC.

Treatment:

Procedure: POES followed by LC