NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061210043

Registered date:13/10/2021

Development of an intraoperative detection system for bile leakage after hepatectomy with indocyanine green

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedPrimary hepatic cancer, metastatic hepatic cancer, benign hepatic tumor
Date of first enrollment13/10/2021
Target sample size85
Countries of recruitment
Study typeInterventional
Intervention(s)ICG administration

Outcome(s)

Primary OutcomeTotal bilirubin concentration in drainage on the 3rd postoperative day
Secondary Outcome1) Incidence of bile leakage after hepatectomy 2) Drainage/serum concentration ratio of total bilirubin on the third postoperative day 3) The number of bile leaks after hepatectomy 4) Changes in total bilirubin concentration and total bilirubin amount per 24 hours in drainage 5) Bacteria in drainage 6) Duration of postoperative hospital stay 7) Safety

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria[Study drug treatment group] 1) Patients undergoing hepatectomy as scheduled surgery for primary hepatic cancer, metastatic hepatic cancer, and benign hepatic tumor, regardless of laparotomy or laparoscopic surgery 2) ECOG-PS<=1 3) Male and female over 20 years old at the time of consent form 4) Patients without serious complications [Historical control group] 1) Patients who underwent hepatectomy and drained for primary hepatic cancer, metastatic hepatic cancer, and benign hepatic tumor before July 2020, regardless of laparotomy or laparoscopic surgery 2) ECOG-PS<=1 3) Male and female over 20 years old at the time of surgery 4) Patients without serious complications
Exclude criteria[Study drug treatment group] 1) Patients undergoing emergency surgery 2) Patients with a history of hypersensitivity to ICG components 3) Patients with a history of iodine hypersensitivity 4) Pregnant women or patients who may be pregnant 5) Lactating patients 6) Patients who participated in other clinical studies within 3 months before registration [Historical control group] 1) Patients undergoing emergency surgery 2) Patients who received ICG at the time of surgery

Related Information

Contact

Public contact
Name Takehiko Hanaki
Address 36-1 Nishi-cho, Yonago, Tottori Tottori Japan 683-8504
Telephone +81-859-38-6567
E-mail t.hanaki@tottori-u.ac.jp
Affiliation Tottori University Hospital
Scientific contact
Name Takehiko Hanaki
Address 36-1 Nishi-cho, Yonago, Tottori Tottori Japan 683-8504
Telephone +81-859-38-6567
E-mail t.hanaki@tottori-u.ac.jp
Affiliation Tottori University Hospital