Modified Laparoscopic Transcystic Biliary Drainage in the Management of Cholecystocholedocholithiasis

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Common Bile Duct Calculi; Acute Cholangitis; Acute; Cholecystitis, Choledocholithiasis; Acute Cholecystitis With Obstruction
• Intervention / Treatment: Procedure: Modified laparoscopic transcystic biliary drainage

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.

• Study Type: Interventional
• Enrollment (Estimated): 310
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: LINGFU ZHANG; Phone Number: +8613488693608; Email: zhanglingfuzlf@126.com

Study Locations

• China
  • None Selected
    • Beijing, None Selected, China, 100191
      • Lingfu Zhang
      • Contact: LINGFU ZHANG; Phone Number: +8613488693608; Email: zhanglingfuzlf@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
anchoring time of the C-tube	the consumption of time from needle puncture to ending of C-tube ligation	6 months
average daily drainage volume	the average volume of bile drainage per day	6 months
early dislodgement of C-tube	the dislodgement of C-tube before intended removal.	6 months

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Chair: LINGFU ZHANG, 北京大学第三医院

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: August 22, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Bile Duct Diseases; Common Bile Duct Diseases; Cholelithiasis; Cholecystolithiasis; Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute; Calculi; Cholangitis; Gallstones; Choledocholithiasis
• Other Study ID Numbers: 81524

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No