Modified Laparoendoscopic Rendezvous for Secondary Choledocholithiasis: a Nonrandomized Controlled Clinical Study

Shenzhen University

Status: Enrolling

Conditions: Choledocholithiasis

Treatments: Procedure: Modified LERV

Study type: Observational

Funder types: Other

Identifiers

NCT05542784

20223357016

Details and patient eligibility

About

This study intends to explore the success rate and clinical efficacy of modified LERV in the treatment of patients with non-dilated common bile duct (internal diameter ≤10mm) through a non-randomized controlled clinical trial, and to clarify whether modified LERV can be used as the preferred routine treatment for choledocholithiasis secondary to gallbladder stones.

Full description

Patients with cholecystolithiasis secondary to common bile duct stones requiring surgical treatment during a 3-year period from 2022-6-1 to 2025-3-31 were enrolled in this non-randomized controlled clinical trial. Preoperative diameter of the middle common bile duct was determined by magnetic resonance cholangiography (MRCP) or B-ultrasound measurement. The actual treatment plan of the patients was recorded, including LERV treatment and ERCP+LC treatment. The baseline data and the success rate of stone removal, operation time, postoperative stone residual rate, complication rate, length of hospital stay and hospitalization cost were recorded for observation and follow-up. To determine whether modified LERV can be used as the preferred routine treatment for choledocholithiasis secondary to gallbladder stones.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1、18 years ≤ age <85 years 2、clinical diagnosis of choledocholithiasis secondary to cholecystolithiasis and middle choledocholithiasis (MCBD) diameter ≤10mm; The diameter of MCBD was based on MRCP measurements. If MRCP could not be performed, CT images were used as reference, and B-ultrasound measurements were used as the standard.

3、 Good cardiopulmonary function, anesthesia evaluation tolerance under general anesthesia laparoscopic + endoscopic surgery.

Exclusion criteria

1、 Intrahepatic bile duct stones with indications for surgery, and need simultaneous surgery; 2、 Patients with choledocholithiasis >2 cm or a large number of stones were difficult to remove; 3、 Patients with malignant hepatobiliary and pancreatic tumors or biliary tract malformations; 4、 Severe patients with severe pancreatitis and septic shock before operation; 5、Patients with previous gastric and duodenoscopic surgery history and interruption of gastroduodenal continuity; 6、 Severe partial stenosis of the upper gastrointestinal tract (from the oral cavity to the second duodenum), which is expected to be inaccessible to the duodenoscope.

Trial design

90 participants in 2 patient groups

Patients with choledocholithiasis secondary to choledocholithiasis undergoing LERV surgery

Treatment:

Procedure: Modified LERV

Patients with choledocholithiasis secondary to choledocholithiasis undergoing PreERCP+LC surgery