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Exploratory clinical study on Indocyanine Green (ICG) navigated lymph node dissection in robot-assisted radical prostatectomy

Exploratory clinical study on Indocyanine Green (ICG) navigated lymph node dissection in robot-assisted radical prostatectomy - RARP-ICG study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024989
Enrollment
70
Registered
2017-02-01
Start date
2017-02-01
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

Prostate cancer

Interventions

After injecting ICG into the prostate gland, observe with a near infrared (NIR) camera and classify lymph flow. The ICG positive site within the template dissection area is dissected and additionally

Sponsors

National Cancer Center Hospital:Tsukiji Campus
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Diagnosed as prostate cancer pathologically by prostate biopsy 2) Diagnosed as localized prostate cancer (T1-2N0M0) or locally advanced cancer (T3aN0M0) by DRE, CT, MRI 3) 20 years old and over, under 75 4) ECOG performance status score: 0 and 1 5) With or without measurable lesions 6) Provision of pretreatment: No history of hormone therapy, no history of surgery in the pelvis, no history of operation of the prostate 7) No restrictions on concomitant medications and combination therapy 8) With regard to complications, there is no restriction as long as it is judged that robot-assisted prostatectomy and extended lymph node dissection is possible by the attending physician 9) About patient participation The patient got consent in writing from the patient himself

Exclusion criteria

Exclusion criteria: Exclude those with allergic history in ICG

Design outcomes

Primary

MeasureTime frame
Lymph flow evaluatable ratio, lymph flow pattern classifiable ratio, lymph flow pattern classifiable ratio by lesion site, classification lymph flow pattern intra-lymph node metastasis rate

Countries

Japan

Contacts

Public ContactTomohiko Hara

National Cancer Center Hospital:Tsukiji Campus Urology division

thara@ncc.go.jp03-3542-2511

Outcome results

None listed

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