Evaluation of intraoperative localization by indocyanine green (ICG) injection for laparoscopic colorectal cancer surgery

Not Applicable

• Conditions: Colon cancer and rectal cancer; colon cancer, rectal cancer

• Registration Number: JPRN-jRCTs031200195
• Lead Sponsor: SHIGEKI YAMAGUCHI

Brief Summary

ICG injection is a useful tool for determining tumor localization. Since no adverse events were observed, it is considered a safe method for intraoperative tumor localization diagnosis.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-11
• Study Completion: 2022-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. Patients who are hospitalized or hospitalized for department of surgery, institute of gastroenterology, Tokyo Women's Medical University.
2. Men and women over the age of 20 at the time of obtaining consent.
3. Patients diagnosed with colon cancer and rectal cancer.
4. Patients scheduled for laparoscopic or robot-assisted surgery for colon cancer and rectal cancer
5. Patients who can undergo lower gastrointestinal endoscopy and local injection 2-3 days before surgery
6. Patients who have a thorough understanding after receiving a sufficient explanation for participation in this study and have the free written consent of the patient.
7. For all inspection items, use the latest inspection values within 56 days before registration. Inspection on the same day 8 weeks before the registration date is allowed. )
A) White blood cell count 3,000 /mm3 or less
B) Platelet count100,000 /mm3 or less
C) AST 100 IU/L or more, ALT 100 IU/L or more
D) Total bilirubin2.0 g/dl ore more
E) Serum creatinine1.5 mg/dl or more

Exclusion Criteria

1. Patients with iodine and ICG allergies.
2. Cases of emergency surgery, cases of severe stenosis, cases of colonic stent placement, and cases judged to be in poor general condition by the principal investigator are excluded.
3. Patients who are judged to be inappropriate by the principal investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
We determine whether the location where the ICG is locally injected with the preoperative colonoscopy can be detected by intraoperative infrared observation.

Secondary Outcome Measures

Name	Time	Method
1. Comparison of identification rate between the India ink tattooing and the ICG local injection <br>2. Histological comparison between the India ink tattooing and the the ICG local injection<br>3. Presence or absence of adverse events associated with infrared light observation and the ICG local injection.<br>4.Evaluate the possibility that regional lymph nodes have luminescent properties by the ICG local injection method.