Modified Laparoscopic Transcystic Biliary Drainage in the Management of Cholecystocholedocholithiasis

NCT ID: NCT06011941

Last Updated: 2023-08-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2027-07-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

modified laparoscopic transcystic biliary drainage

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.

Group Type: EXPERIMENTAL

Modified laparoscopic transcystic biliary drainage

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

LINGFU ZHANG

Role: STUDY_CHAIR

北京大学第三医院

Locations

Lingfu Zhang

Beijing, None Selected, China

Countries

China

Central Contacts

LINGFU ZHANG

Role: CONTACT

zhanglingfuzlf@126.com

+8613488693608

Facility Contacts

LINGFU ZHANG

Role: primary

zhanglingfuzlf@126.com

+8613488693608

References

Zhang LF, Hou CS, Xu Z, Wang LX, Ling XF, Wang G, Cui L, Xiu DR. [Clinical effect of laparoscopic transcystic drainage combined with common bile duct exploration for the patients with difficult biliary stones]. Beijing Da Xue Xue Bao Yi Xue Ban. 2022 Dec 18;54(6):1185-1189. doi: 10.19723/j.issn.1671-167X.2022.06.021. Chinese.

Reference Type: BACKGROUND

PMID: 36533353 (View on PubMed)

Zhang YY, Wang G, Hou C, Xu Z, Wang L, Cui L, Ling X, Zhang L. Safety and effectiveness of modified laparoscopic transcystic biliary drainage in the treatment of choledocholithiasis: study protocol for a prospective single-arm clinical trial. BMJ Open. 2025 Apr 23;15(4):e089540. doi: 10.1136/bmjopen-2024-089540.

Reference Type: DERIVED

PMID: 40268483 (View on PubMed)

Other Identifiers

81524

Identifier Type: -

Identifier Source: org_study_id