Clincosm LogoSign in Get a demo

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

Sponsor
Shanghai Zhongshan Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04658212
Collaborator
(none)
300
Enrollment
2
Arms
41.9
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: 3D LCBDE
  • Procedure: ERCP
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Multicenter Randomized Controlled Study of 3D Laparoscopy Versus Endoscopy in the Treatment of Choledocholithiasis
Anticipated Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 3D LCBDE group

Procedure: 3D LCBDE
three-dimensional (3D) video system for LCBDE (laparoscopic cholecystectomy and laparoscopic common bile duct exploration )
Active Comparator: ERCP group

Procedure: ERCP
Endoscopic retrograde cholangiopancreatography (ERCP)

Outcome Measures

Primary Outcome Measures

  1. Perioperative Complication Rate [1 month after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shanghai Zhongshan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT04658212
Other Study ID Numbers:
  • ZSBS-LSES-1
First Posted:
Dec 8, 2020
Last Update Posted:
Dec 8, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Choledocholithiasis

Study Results

No Results Posted as of Dec 8, 2020