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An Exploratory Study Evaluating the Safety of Urinary Tract Imaging Using Intra-urinary Indocyanine Green Administration During Robot-Assisted Partial Nephrectomy

An Exploratory Study Evaluating the Safety of Urinary Tract Imaging Using Intra-urinary Indocyanine Green Administration During Robot-Assisted Partial Nephrectomy

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031250821
Enrollment
5
Registered
2026-03-18
Start date
2026-03-18
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

Renal tumor Renal tumor

Interventions

Indocyanine green (ICG) will be administered into the urinary tract for urinary tract imaging using near-infrared fluorescence observation in patients with renal tumors undergoing robot-assisted parti
Indocyanine green (ICG)

Sponsors

Yamada Yuta
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients scheduled to undergo Robot-Assisted Partial Nephrectomy (RAPN) for renal tumors. (2) Age: Patients aged >= 18 years at the time of obtaining consent. (3) Gender: Any. (4) Patients who have provided written informed consent of their own free will after receiving a full explanation regarding participation in this study and fully understanding its contents.

Exclusion criteria

Exclusion criteria: (1)Patients with a history of hypersensitivity to indocyanine green (ICG) or iodine contrast agents. (2) Patients with severe hepatic dysfunction equivalent to Child-Pugh Class C. (3) Patients with serious heart disease or respiratory disease judged to be at high risk for general anesthesia. (4)Patients judged preoperatively to have technical difficulties with ureteral stent placement (including severe ureteral stenosis, history of urinary tract reconstruction, anatomical abnormalities, etc.). (5)Patients judged to have difficulty fully understanding the content of this study due to severe cognitive impairment, etc., making it difficult to obtain appropriate consent. (6) Patients who are pregnant or possibly pregnant. (7) Patients who are breastfeeding. (8)Others judged by the principal investigator or co-investigator to be inappropriate for participation in this study.

Design outcomes

Primary

MeasureTime frame
Percentage of cases in which intra-urinary ICG administration and near-infrared fluorescence observation procedures were completed without adverse events requiring additional intraoperative measures.

Secondary

MeasureTime frame
(1) Surgeon evaluation score regarding recognition of urinary tract boundaries (Likert scale). (2) Detection rate of urinary tract opening (urinary tract injury) after resection. (3) Ischemia time. (4) Console time. (5) Estimated blood loss. (6) Urinary tract-related complications occurring within 7 days postoperatively (evaluated by Clavien-Dindo classification). (7) Frequency and proportion of adverse events.

Contacts

Public ContactYuta Yamada

The University of Tokyo Hospital

YAMADAYU-URO@h.u-tokyo.ac.jp+81-338155411

Outcome results

None listed

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