Study about the effectiveness of localization and drainage lymph flow confirmation of colorectal cancer using near infrared light.

JRCT ID: jRCTs041200001

Registered date:13/04/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Colorectal cancer
• Date of first enrollment: 13/04/2020
• Target sample size: 300
• Study type: Other
• Intervention(s): Preoperative ICG local injection.

Outcome(s)

• Primary Outcome: 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

3-year recurrence free survival
3-year overall survival
Safety and short-term results (perioperative complications, postoperative hospital stay)
Identification rate of tumor localization by ICG marking.
Number of isolated lymph nodes.
Number of ICG fluorescent lymph nodes.
Number of metastatic lymph nodes.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Takemasa Ichiro