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NCT04658212 Clinical Trial

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

Choledocholithiasis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04658212
Other study ID # ZSBS-LSES-1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date June 30, 2024

Study information
Verified date December 2020
Source Shanghai Zhongshan Hospital
Contact Yueqi Wang, PhD
Phone 15901669460
Email yueqiwang@fudan.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date June 30, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• 3D LCBDE
three-dimensional (3D) video system for LCBDE (laparoscopic cholecystectomy and laparoscopic common bile duct exploration )
• ERCP
Endoscopic retrograde cholangiopancreatography (ERCP)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Perioperative Complication Rate 1 month after surgery
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