A Multicenter Randomized Controlled Study of 3D Laparoscopy Versus Endoscopy in the Treatment of Choledocholithiasis
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About
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.
Enrollment
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Inclusion criteria
- 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
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
300 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Yueqi Wang, PhD
Data sourced from clinicaltrials.gov
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