The efficacy of leakage test performed with intraoperative ultrasonic cholangiography in hepatic resection

JRCT ID: jRCTs051180027

Registered date:17/01/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hepatic resection
• Date of first enrollment: 02/08/2018
• Target sample size: 100
• Countries of recruitment: No,Japan
• Study type: Interventional
• Intervention(s): Leak test is intraoperatively performed by injecting sonazoid and indigo carmine into bile duct after hepatic resection for all cases.

Outcome(s)

• Primary Outcome: Successful of leak test after hepatic resection
• Secondary Outcome: The event of postoperative bile leakage

Key inclusion & exclusion criteria

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

Include criteria

1.Patients over 20 years of age at the informed consent
2.Patients who will undergo hepatic resection without biliary reconstruction.
3.Patients who needs cholecystectomy at hepatic resection
4.Patients who had no side effect for contrast enhanced ultrasonography using intravenous injection of sonazoid as preoperative examination
5.Patients who had an explanation about this study and written informed consent is obtained.

Exclude criteria

1.Patients who had an allergic event for sonazoid or indigo carmine
2.Patients who had an allergy to egg or egg products
3.Patients who have cholecystitis or cholangitis preoperatively
4.Patients who have a history of cholecystectomy
5.Patients whom investigator or subinvestigators decide unsuitable as subjects of this study.

Related Information

• Primary Sponsor: Komatsu Shohei
• Secondary ID(s): UMIN000031236