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

Completed

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

• Registration Number: jRCTs061210043

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-13
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: Complete
• 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: single assignment

Primary Outcome Measures

Name	Time	Method
-		Total bilirubin concentration in drainage on the 3rd postoperative day