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A Multicenter Randomized Controlled Study of 3D Laparoscopy Versus Endoscopy in the Treatment of Choledocholithiasis

Primary Purpose

Choledocholithiasis, ERCP

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
3D LCBDE
ERCP
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choledocholithiasis

Eligibility Criteria

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

Inclusion Criteria:

  1. The diagnosis of choledocholithiasis based on preoperative image studies including abdominal ultrasonography, computed tomography (CT), and/or magnetic resonance cholangiopancreatography (MRCP) with relevant supporting laboratory examinations
  2. Age <80y and >18y
  3. Non-emergency surgery

Exclusion Criteria:

  1. Diagnosis of Mirizzi's syndrome,
  2. Acute suppurative cholangitis
  3. Detection of bilioenteric anastomosis
  4. Pathological diagnosis of cholangiocarcinoma
  5. Extended surgery due to multiple biliary strictures,
  6. Intrahepatic stones

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    3D LCBDE group

    ERCP group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Perioperative Complication Rate

    Secondary Outcome Measures

    Full Information

    First Posted
    November 21, 2020
    Last Updated
    December 4, 2020
    Sponsor
    Shanghai Zhongshan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04658212
    Brief Title
    A Multicenter Randomized Controlled Study of 3D Laparoscopy Versus Endoscopy in the Treatment of Choledocholithiasis
    Official Title
    A Multicenter Randomized Controlled Study of 3D Laparoscopy Versus Endoscopy in the Treatment of Choledocholithiasis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Zhongshan Hospital

    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 incidence of choledocholithiasis is gradually rising with the increase of gallstone incidence. The popular minimally invasive treatment options include endoscopic retrograde cholangiopancreatography (ERCP) and laparoscopic common bile duct exploration (LCBDE). Currently, three-dimensional (3D) video system for laparoscopy is developed to ofer surgeon a superior depth perception and a much better user experience, thus potential increasing operation accuracy and stability. It have suggested that compared with 2D laparoscopy, 3D laparoscopy can effectively reduce operation time and numbers of errors. However, rare experimental studies are performed to evaluate the safety and effectiveness of 3D laparoscopy in choledocholithiasis patients. The aim of this study is to compare the perioperative outcomes between 3D laparoscopy and ERCP in choledocholithiasis patients through a multicenter randomized controlled design.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Choledocholithiasis, ERCP

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    3D LCBDE group
    Arm Type
    Experimental
    Arm Title
    ERCP group
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    3D LCBDE
    Intervention Description
    three-dimensional (3D) video system for LCBDE (laparoscopic cholecystectomy and laparoscopic common bile duct exploration )
    Intervention Type
    Procedure
    Intervention Name(s)
    ERCP
    Intervention Description
    Endoscopic retrograde cholangiopancreatography (ERCP)
    Primary Outcome Measure Information:
    Title
    Perioperative Complication Rate
    Time Frame
    1 month after surgery

    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: The diagnosis of choledocholithiasis based on preoperative image studies including abdominal ultrasonography, computed tomography (CT), and/or magnetic resonance cholangiopancreatography (MRCP) with relevant supporting laboratory examinations Age <80y and >18y Non-emergency surgery Exclusion Criteria: Diagnosis of Mirizzi's syndrome, Acute suppurative cholangitis Detection of bilioenteric anastomosis Pathological diagnosis of cholangiocarcinoma Extended surgery due to multiple biliary strictures, Intrahepatic stones
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yueqi Wang, PhD
    Phone
    15901669460
    Email
    yueqiwang@fudan.edu.cn

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Multicenter Randomized Controlled Study of 3D Laparoscopy Versus Endoscopy in the Treatment of Choledocholithiasis

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