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

Not Applicable

• Conditions: Choledocholithiasis; ERCP
• Interventions: Procedure: 3D LCBDE; Procedure: ERCP

• Registration Number: NCT04658212
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-21
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-04
• Last Update Submitted: 2020-12-04
• Study First Posted: 2020-12-08
• Last Update Posted: 2020-12-08
• Study Start: 2021-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D LCBDE group	3D LCBDE	-
ERCP group	ERCP	-

Primary Outcome Measures

Name	Time	Method
Perioperative Complication Rate	1 month after surgery