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An open-label, non-randomized clinical study of the development of an intraoperative detection system for bile leakage after hepatectomy with indocyanine green

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

Hanaki Takehiko

Tottori University Hospital

36-1 Nishi-cho, Yonago, Tottori

t.hanaki@tottori-u.ac.jp

Hanaki Takehiko

Tottori University Hospital

36-1 Nishi-cho, Yonago, Tottori

+81-859-38-6567

t.hanaki@tottori-u.ac.jp

Complete

Oct. 13, 2021

Interventional

non-randomized controlled trial

open(masking not used)

historical control

single assignment

treatment purpose

[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

[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

Both

Primary hepatic cancer, metastatic hepatic cancer, benign hepatic tumor

ICG administration

Total bilirubin concentration in drainage on the 3rd postoperative day

1) 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

+81-859-38-7021

No

none