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

NCT04658212 | Unknown

• 1 other identifier: ZSBS-LSES-1
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Choledocholithiasis; ERCP

Outcome Measures

Primary Outcomes (1)

• Perioperative Complication Rate

  1 month after surgery

Study Arms (2)

3D LCBDE group

EXPERIMENTAL

Procedure: 3D LCBDE

ERCP group

ACTIVE COMPARATOR

Procedure: ERCP

Interventions

3D LCBDE PROCEDURE

three-dimensional (3D) video system for LCBDE (laparoscopic cholecystectomy and laparoscopic common bile duct exploration )

3D LCBDE group

ERCP PROCEDURE

Endoscopic retrograde cholangiopancreatography (ERCP)

ERCP group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Choledocholithiasis

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Yueqi Wang, PhD

CONTACT

15901669460; yueqiwang@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2020
• First Posted: December 8, 2020
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share