Modified Laparoscopic Transcystic Biliary Drainage in the Management of Cholecystocholedocholithiasis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorPeking University Third Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients ≥ 18 years of age;

Patients with gallbladder stones and known or expected concomitant bile duct stones;

Informed consent.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Modified laparoscopic transcystic biliary drainage

    Procedure/Surgery

    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.

Treatment groups

310 Participants
are divided into 1 treatment group
Group A: modified laparoscopic transcystic biliary drainageExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months
2

bile leakage

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 outcomes

1

anchoring time of the C-tube

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

Time frame
6 months
2

average daily drainage volume

the average volume of bile drainage per day

Time frame
6 months
3

early dislodgement of C-tube

the dislodgement of C-tube before intended removal.

Time frame
6 months

Other outcomes

Sponsors and contacts

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