Modified Laparoscopic Transcystic Biliary Drainage in the Management of Cholecystocholedocholithiasis

Peking University

Status: Not yet enrolling

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

Treatments: Procedure: Modified laparoscopic transcystic biliary drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT06011941

81524

Details and patient eligibility

About

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.

Full 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.

Enrollment: 310 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients ≥ 18 years of age;
• Patients with gallbladder stones and known or expected concomitant bile duct stones;
• Informed consent.

Exclusion criteria

• Biliary drainage is already present, e.g. preoperative ENBD, PTCD;
• Women who are pregnant;
• Declined consent;
• Inability to follow the procedures of the study, e.g. due to language problems and psychological disorders of the participant;
• Morbid obesity (BMI > 40);
• IV-VI class of the American Society of Anesthesiologists physical status classification;
• Contraindications for general anesthesia or surgery.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

310 participants in 1 patient group

modified laparoscopic transcystic biliary drainage

Experimental group

Description:

A 7-Fr triple-lumen 30-cm central venous catheter was adopted to replace conventional 5-Fr ureteral catheter. Then we developed a continued suture and circling manner by the V-Loc closure device, 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.

Treatment:

Procedure: Modified laparoscopic transcystic biliary drainage