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Modified Laparoscopic Transcystic Biliary Drainage in the Management of Cholecystocholedocholithiasis

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Modified laparoscopic transcystic biliary drainage
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Bile Duct Calculi

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Lingfu Zhang

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

modified laparoscopic transcystic biliary drainage

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

anchoring time of the C-tube
the consumption of time from needle puncture to ending of C-tube ligation
average daily drainage volume
the average volume of bile drainage per day
early dislodgement of C-tube
the dislodgement of C-tube before intended removal.

Full Information

First Posted
August 22, 2023
Last Updated
August 22, 2023
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06011941
Brief Title
Modified Laparoscopic Transcystic Biliary Drainage in the Management of Cholecystocholedocholithiasis
Official Title
Safety and Feasibility of Modified Laparoscopic Transcystic Biliary Drainage in the Management of Cholecystocholedocholithiasis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
July 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Bile Duct Calculi, Acute; Cholecystitis, Choledocholithiasis, Acute Cholecystitis With Obstruction, Acute Cholangitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
310 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
modified laparoscopic transcystic biliary drainage
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Modified laparoscopic transcystic biliary drainage
Intervention Description
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.
Primary Outcome Measure Information:
Title
postoperative overall morbidity
Description
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.
Time Frame
6 months
Title
bile leakage
Description
Bile leakage is determined according to the definition and grading of severity by the International Study Group of Liver Surgery.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
anchoring time of the C-tube
Description
the consumption of time from needle puncture to ending of C-tube ligation
Time Frame
6 months
Title
average daily drainage volume
Description
the average volume of bile drainage per day
Time Frame
6 months
Title
early dislodgement of C-tube
Description
the dislodgement of C-tube before intended removal.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LINGFU ZHANG
Phone
+8613488693608
Email
zhanglingfuzlf@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LINGFU ZHANG
Organizational Affiliation
北京大学第三医院
Official's Role
Study Chair
Facility Information:
Facility Name
Lingfu Zhang
City
Beijing
State/Province
None Selected
ZIP/Postal Code
100191
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LINGFU ZHANG
Phone
+8613488693608
Email
zhanglingfuzlf@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36533353
Citation
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.
Results Reference
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Modified Laparoscopic Transcystic Biliary Drainage in the Management of Cholecystocholedocholithiasis

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