NCT05542784

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: Shenzhen Second People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Choledocholithiasis

Interventions

Type	Name	Description
PROCEDURE	Modified LERV	Patients routinely underwent LC. The ligature clamp clamps the distal end of the capsule tube. In this case, you need to perform two steps: Laparoscopic operation: proximal incision, anterograde placement of guide wire into the duodenum. The catheter was removed and the balloon dilated. The balloon was released and removed when the ERCP was initiated for cannulation. After successful ERCP retrograde placement, the anterograde guide wire was pulled out and the gallbladder was removed. ERCP procedure: After the anterograde guide wire was observed by duodenoscope, duodenal papilla was placed through a retrograde incision along the anterograde guide wire, and a retrograde cannula was inserted into the common bile duct. Remove stones by dragging them with a net basket or/and balloon. Angiography confirmed that there was no filling defect in the extrahepatic bile duct, and ENBD was indwelled.

Timeline

• Start date: 2022-06-01
• Primary completion: 2025-03-01
• Completion: 2025-07-01
• First posted: 2022-09-15
• Last updated: 2022-09-15

Locations

1 site across 1 country: China