Trials / Completed
CompletedNCT05734144
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 432 (actual)
- Sponsor
- Zagazig University · Other Government
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
| PROCEDURE | POES followed by LC | Treatment in two stages, which combines a preoperative ES followed by LC (sequential treatment). |
Timeline
- Start date
- 2010-01-01
- Primary completion
- 2022-04-01
- Completion
- 2022-12-01
- First posted
- 2023-02-17
- Last updated
- 2023-02-17
Source: ClinicalTrials.gov record NCT05734144. Inclusion in this directory is not an endorsement.