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Clinical study on sentinel pelvic lymphnode analysis with Indocyanine Green (ICG) navigation for prostate cancer and bladder cancer using da Vinci Xi system

Clinical study on sentinel pelvic lymphnode analysis with Indocyanine Green (ICG) navigation for prostate cancer and bladder cancer using da Vinci Xi system - Xi-ICG pelvic sentinel node study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000026384
Enrollment
100
Registered
2017-05-01
Start date
2017-04-01
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, bladder cancer

Interventions

After injecting ICG into the prostate gland, observe with a near infrared camera on the da Vinci Xi system and classify lymph flow. The ICG positive site within the template dissection area is dissect

Sponsors

Department of Urology, St. Luke's International Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) For the cases of the robotic radical prostatectomy or cystectomy using da Vinci Xi system with clinical stage T1-T3N0-M0 2) 35 years old and over, under 85 3) ECOG performance status score: 0 and 1 4) Preserving the major organ functions for geneneral anesthesia by general condition workup within the prior 3months 5) With written consent forms by the patients themselves

Exclusion criteria

Exclusion criteria: 1)Excluded those with allergic history of ICG 2)The cases with inappropriate for this study made by the persons in charge

Design outcomes

Primary

MeasureTime frame
Lynmph flow pattern ratio, the accuracy rate of sentinel lymph nodes

Secondary

MeasureTime frame
Comparison between conventional lymph node templates and sentinel lymph nodes, safty of indocyanine green administration

Countries

Japan

Contacts

Public ContactMasaki Shimbo

St.Luke's International Hospital Department of Urology

mashimbo@luke.ac.jp03-3541-5151

Outcome results

None listed

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