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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04658212

Enrollment

300

Registered

2020-12-08

Start date

2021-01-01

Completion date

2024-06-30

Last updated

2020-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choledocholithiasis, ERCP

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.

Interventions

PROCEDURE3D LCBDE

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

PROCEDUREERCP

Endoscopic retrograde cholangiopancreatography (ERCP)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Perioperative Complication Rate	1 month after surgery

Contacts

Primary ContactYueqi Wang, PhD

yueqiwang@fudan.edu.cn15901669460

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026