Clinical trial NCT06011941: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Common Bile Duct Calculi
Acute; Cholecystitis, Choledocholithiasis
Acute Cholecystitis With Obstruction
Acute Cholangitis
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: postoperative overall morbidity
timeFrame: 6 months
measure: bile leakage
timeFrame: 6 months
Secondary outcomes:
measure: anchoring time of the C-tube
timeFrame: 6 months
measure: average daily drainage volume
timeFrame: 6 months
measure: early dislodgement of C-tube
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lingfu Zhang
state: None Selected
Study officials:
affiliation: 北京大学第三医院
name: LINGFU ZHANG
role: STUDY_CHAIR
References:
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.