Common Bile Duct Calculi Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 310 |
Est. completion date | July 1, 2027 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Lingfu Zhang | Beijing | None Selected |
Lead Sponsor | Collaborator |
---|---|
Peking University Third Hospital |
China,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | anchoring time of the C-tube | the consumption of time from needle puncture to ending of C-tube ligation | 6 months | |
Secondary | average daily drainage volume | the average volume of bile drainage per day | 6 months | |
Secondary | early dislodgement of C-tube | the dislodgement of C-tube before intended removal. | 6 months |
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