Modified Laparoscopic Transcystic Biliary Drainage in the Management of Cholecystocholedocholithiasis

Common Bile Duct Calculi Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06011941
• Other study ID #: 81524
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: July 1, 2027

Study information

• Verified date: August 2023
• Source: Peking University Third Hospital
• Contact: LINGFU ZHANG
• Phone: +8613488693608
• Email: zhanglingfuzlf[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Acute Cholangitis
• Acute Cholecystitis With Obstruction
• Acute; Cholecystitis, Choledocholithiasis
• Calculi
• Cholangitis
• Cholecystitis
• Cholecystitis, Acute
• Choledocholithiasis
• Common Bile Duct Calculi
• Gallstones

Intervention

Procedure:
• Modified laparoscopic transcystic biliary drainage
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.

Locations

Country	Name	City	State
China	Lingfu Zhang	Beijing	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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

Outcome

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