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

Phase 2

Recruiting

• Conditions: Primary hepatic cancer, metastatic hepatic cancer, benign hepatic tumor

• Registration Number: JPRN-jRCTs061210043
• Lead Sponsor: Hanaki Takehiko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 85

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified