Modified Laparoscopic Transcystic Biliary Drainage in the Management of Cholecystocholedocholithiasis

NCT06011941 | Not Yet Recruiting

• 1 other identifier: 81524
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• postoperative overall morbidity

  All outcome variables will be assessed according to internationally accepted standards if available, that is, the consensus definitions for surgical and medical complications according to the Clavien-Dindo classification.

  6 months

• bile leakage

  Bile leakage is determined according to the definition and grading of severity by the International Study Group of Liver Surgery.

  6 months

Secondary Outcomes (3)

• anchoring time of the C-tube

  6 months

• average daily drainage volume

  6 months

• early dislodgement of C-tube

  6 months

Study Arms (1)

modified laparoscopic transcystic biliary drainage

EXPERIMENTAL

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.

Procedure: Modified laparoscopic transcystic biliary drainage

Interventions

Modified laparoscopic transcystic biliary drainage 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.

modified laparoscopic transcystic biliary drainage

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Lingfu Zhang

Beijing, None Selected, 100191, China

Location

Related Publications (2)

• 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.

  PMID: 36533353 BACKGROUND

• 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.

  PMID: 40268483 DERIVED

MeSH Terms

Conditions

Gallstones; Cholecystitis; Choledocholithiasis

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Common Bile Duct Diseases; Bile Duct Diseases

Study Officials

• LINGFU ZHANG

  北京大学第三医院

  STUDY CHAIR

Central Study Contacts

LINGFU ZHANG

CONTACT

+8613488693608; zhanglingfuzlf@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 25, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)