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

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

Status
Recruiting
Phases
Unknown
Study type
Unknown
Source
JPRN
Registry ID
JPRN-jRCTs041200001
Enrollment
300
Registered
2020-04-13
Start date
2020-04-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

Preoperative ICG local injection.

Sponsors

Takemasa Ichiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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. OSNA-positive rate.

Contacts

Public ContactHidekazu Takahashi

Osaka International Medical & Science Center Osaka Keisatsu Hospital

htakahashi@gesurg.med.osaka-u.ac.jp+81-6-6771-6051

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026