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NCT Number: NCT06011941

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. postoperative overall morbidity

    Time frame: 6 months

    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.

  2. bile leakage

    Time frame: 6 months

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

Secondary outcomes

  1. anchoring time of the C-tube

    Time frame: 6 months

    the consumption of time from needle puncture to ending of C-tube ligation

  2. average daily drainage volume

    Time frame: 6 months

    the average volume of bile drainage per day

  3. early dislodgement of C-tube

    Time frame: 6 months

    the dislodgement of C-tube before intended removal.

Study contacts

Contact information is provided by the study sponsor or research team.

LINGFU ZHANG

CONTACT

[email protected]

+8613488693608

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 25, 2023
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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