Clinical trial NCT05734144: Two Institutes Experience in Laparo-Endoscopic Rendezvous Technique for Gallbladder and Bile Duct Stones
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Calculus; Gallbladder, With Cholecystitis
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2023-02-17
Enrollment: 432
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was carried out on 432 patients with gall bladder stones and with suspected or confirmed CBDS at two centers 264 patients at the Gastrointestinal Surgery Unit in the Zagazig University Hospitals and 168 patients at gastroenterology surgery unite at ALAHRAR hospitals from January 2010 till May 2022. Patients were randomized divided into two equally groups, the first group was treated by a single-step procedure combining LC and IOES while the second (control) group was treated by 2-stage (sequential treatment) POES followed by LC.
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: successful stone clearance from the CBD
timeFrame: first year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: