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

Primary Purpose

Calculus; Gallbladder, With Cholecystitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The intraoperative ERCP has been performed immediately before LC
POES followed by LC
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Calculus; Gallbladder, With Cholecystitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients having stone in the gallbladder and concurrent CBD stone, as determined by MRCP or US. 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: Patients with history of hepatobiliary surgery as choledocho-duodenal anastomosis. Patients with previous ERCP attempt. Patients with previous upper abdominal surgery as total or partial gastric resection. Patients with morbid obesity. Patients with uncorrectable coagulopathy. Patients aged below 18 years or above 80 years. Patients within the American Society of Anesthesiology (ASA) class 4 and 5 disease. Patients who refused to give consent or participate in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    Laparo-endoscopic "rendezvous" technique

    POES followed by LC

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    successful stone clearance from the CBD
    To ensure that the bile duct was completely clear, a check cholangiogram was conducted.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 3, 2023
    Last Updated
    February 14, 2023
    Sponsor
    Zagazig University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05734144
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2010 (Actual)
    Primary Completion Date
    April 2022 (Actual)
    Study Completion Date
    December 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zagazig University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Calculus; Gallbladder, With Cholecystitis

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    ParticipantCare Provider
    Masking Description
    both the participant patients and the surgeon had no knowledge about the chosen procedure and the choosen procedure were known by the investigator who told the surhgeon later which procedure to perform for the selected patient.
    Allocation
    Randomized
    Enrollment
    432 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Laparo-endoscopic "rendezvous" technique
    Arm Type
    Active Comparator
    Arm Description
    the first group was treated by a single-step procedure combining LC and IOES
    Arm Title
    POES followed by LC
    Arm Type
    Other
    Arm Description
    the second (control) group was treated by 2-stage (sequential treatment) POES followed by LC.
    Intervention Type
    Procedure
    Intervention Name(s)
    The intraoperative ERCP has been performed immediately before LC
    Intervention Description
    combination approach has been used to improve patient compliance and shorten hospital stays. The intraoperative ERCP has been performed immediately before Laparoscopic Cholecystectomy
    Intervention Type
    Procedure
    Intervention Name(s)
    POES followed by LC
    Intervention Description
    Treatment in two stages, which combines a preoperative ES followed by LC (sequential treatment).
    Primary Outcome Measure Information:
    Title
    successful stone clearance from the CBD
    Description
    To ensure that the bile duct was completely clear, a check cholangiogram was conducted.
    Time Frame
    first year postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients having stone in the gallbladder and concurrent CBD stone, as determined by MRCP or US. 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: Patients with history of hepatobiliary surgery as choledocho-duodenal anastomosis. Patients with previous ERCP attempt. Patients with previous upper abdominal surgery as total or partial gastric resection. Patients with morbid obesity. Patients with uncorrectable coagulopathy. Patients aged below 18 years or above 80 years. Patients within the American Society of Anesthesiology (ASA) class 4 and 5 disease. Patients who refused to give consent or participate in the study.

    12. IPD Sharing Statement

    Learn more about this trial

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

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