Intraoperative ultrasonic cholangiography

JRCT ID: jRCTs051230202

Registered date:13/03/2024

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

Hepatectomy
Donor for living donor liver transplantation

• Date of first enrollment: 13/03/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): cholangiography

Outcome(s)

• Primary Outcome: Time for intraoperative cholangiography

Secondary Outcome

Satisfaction with the cholangiography method by means of a questionnaire to the surgeons
Accuracy of cholangiography
Perioperative incidence of biliary tract-related complications (bile leak, bile duct stricture)
Comparison of accuracy of cholangiography method with another method in case of cholangiography failure
The safety in off-label use of sonazoid
Mortality rate, incidence of complications, blood loss, blood transfusion, operation time, postoperative hospital stay

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients who are 20 years of age or older at the time consent is obtained
(2) Patients who meet any of the following conditions; Hepatectomy is the first-line treatment for hepatobiliary diseases, Donors undergoing partial hepatectomy for living donor liver transplantation
(3) Patients who need to undergo cholecystectomy as a liver resection procedure
(4) Patients requiring resection of more than one area for hepatectomy
(5) Patients who have been fully informed of the study and have given their written consent prior to enrollment in the study

Exclude criteria

(1) Patients with a history of hypersensitivity to sonazoid or urographin components
(2) Patients allergic to eggs or egg products
(3) Patients with serious thyroid disease
(4) Patients with preoperative complications such as cholecystitis or cholangitis
(5) Patients participating in other clinical interventional studies
(6) Patients who are judged to be inappropriate for this study by the principal investigator and subinvestigators (hereafter referred to as "principal investigators") for other reasons.

Related Information

• Primary Sponsor: Urade Takeshi