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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Modified laparoscopic transcystic biliary drainage
Procedure/SurgeryFirst, 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
Trial outcomes
Primary outcomes
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 outcomes
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.
Sponsors and contacts
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