NCT06011941

Modified Laparoscopic Transcystic Biliary Drainage in the Management of Cholecystocholedocholithiasis

Safety and Feasibility of Modified Laparoscopic Transcystic Biliary Drainage in the Management of Cholecystocholedocholithiasis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 310 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The modified laparoscopic transcystic biliary drainage which we developed in the treatment of cholecystocholedocholithiasis has some advantages over conventional techniques. Here, a 7-Fr triple-lumen 30-cm central venous catheter was adopted to replace conventional 5-Fr ureteral catheter, which extended the function of the C-tube. Then we developed a continued suture and circling manner by the V-Loc closure device, which simultaneously covered and anchored the C-tube. Theoretically, this modified laparoscopic transcystic drainage not only provide safe and effective bile duct drainage, but also provide a convenient access of treatment for postoperatively retained bile duct stones, which may expand the indication of initially laparoscopic operation in the management of cholecysto-choledocholithiasis.

Detailed description

The modified laparoscopic transcystic biliary drainage which we developed in the treatment of cholecystocholedocholithiasis has some advantages over conventional techniques. Here, a 7-Fr triple-lumen 30-cm central venous catheter was adopted (Arrow International Inc., Pennsylvania, U.S.A.) to replace conventional 5-Fr ureteral catheter, which extended the function of the C-tube. Then we developed a continued suture and circling manner by the V-Loc closure device (Covidien V-Loc 180 3-0®, Mansfield, MA, US), which simultaneously covered and anchored the C-tube. Furthermore, the catheter was introduced through the abdominal wall located at 3 cm below the costal margin on the midaxillary line/the posterior axillary line, which was traditionally performed at the point below the midclavicular line on the right side. Our modified path could avoid the compression of the C-tube by hepatic margin and hence decrease the dislocation of the C-tube. In addition, the retroperitoneal path may increase adherence development and sinus-tract formation. More importantly, this path could easily be available when the patient be placed in the prone position for ERCP, which can conveniently facilitate the guidewire passed through the C-tube down to the duodenum to perform postoperative rendezvous technique. Theoretically, this modified laparoscopic transcystic drainage not only provide safe and effective bile duct drainage, but also provide a convenient access of treatment for postoperatively retained bile duct stones, which may expand the indication of initially laparoscopic operation in the management of cholecysto-choledocholithiasis.

Conditions

• Common Bile Duct Calculi
• Acute; Cholecystitis, Choledocholithiasis
• Acute Cholecystitis With Obstruction
• Acute Cholangitis

Interventions

Type	Name	Description
PROCEDURE	Modified laparoscopic transcystic biliary drainage	First, a needle was passed through a separate skin puncture wound 3 cm below the costal margin on the midaxillary line/posterior axillary line. Second, a lateral incision into the cystic duct was performed medially to allow insertion and embedding of the catheter. Third, a 7-Fr catheter was introduced through the abdominal wall via the cystic duct into the CBD. Fourth, if the position of the catheter inside the CBD was correct (the end of the tube reached the distal CBD but did not pass the papilla), the lateral incision of the cystic duct was closed by a V-Loc closure device using a single-layered, continuous suture in a circling manner to simultaneously cover and anchor the C-tube. After the procedure, an artificial fistula of 3 to 5 mm in length was formed.

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-12-31
• Completion: 2027-07-01
• First posted: 2023-08-25
• Last updated: 2023-08-25

Locations

1 site across 1 country: China