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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Choledocholithiasis; ERCP
• Intervention / Treatment: Procedure: 3D LCBDE; Procedure: ERCP

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yueqi Wang, PhD; Phone Number: 15901669460; Email: yueqiwang@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Perioperative Complication Rate	1 month after surgery

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): June 30, 2024

Study Registration Dates

• First Submitted: November 21, 2020
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (ACTUAL): December 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 4, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Common Bile Duct Diseases; Cholelithiasis; Choledocholithiasis
• Other Study ID Numbers: ZSBS-LSES-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No