Study about the effectiveness of localization and drainage lymph flow confirmation of colorectal cancer using near infrared light.
Not Applicable
Recruiting
- Conditions
- Colorectal cancer
- Registration Number
- JPRN-jRCTs041200001
- Lead Sponsor
- Takemasa Ichiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
1)Age at the time of obtaining consent is 20 years or older.
2)Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
3)Primary colorectal cancer
4)Histological confirmation of colorectal cancer (adenocarcinoma).
5) A radical operation is planned.
6) Informed consent has been obtained.
Exclusion Criteria
1)A case in which lower endoscope is difficult before surgery.
2)A case with indocyanine green hypersensitivity
3)A case with iodine hypersensitivity
4)Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. Men with no intention to practice birth control.
5)Inadequate physical condition, as diagnosed by primary physician.
Study & Design
- Study Type
- Other
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Metastatic positive rate of ICG fluorescent lymph nodes and metastatic positive rate of ICG non-fluorescent lymph nodes in regional and not regional lymph nodes.
- Secondary Outcome Measures
Name Time Method 3-year recurrence free survival<br>3-year overall survival<br>Safety and short-term results (perioperative complications, postoperative hospital stay)<br>Identification rate of tumor localization by ICG marking.<br>Number of isolated lymph nodes.<br>Number of ICG fluorescent lymph nodes.<br>Number of metastatic lymph nodes.