Renal tumor Renal tumor
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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
The University of Tokyo Hospital