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Clinical study for Robot-assisted partial nephrectomy with da Vinci Si

Clinical study for Robot-assisted partial nephrectomy with da Vinci Si - Clinical study for Robot-assisted partial nephrectomy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000028133
Enrollment
10
Registered
2017-08-01
Start date
2017-08-01
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

Renal Cell Carcinoma

Interventions

Diagnosed with renal cell carcinoma and the clinical stage T1a (tumors less than 4 cm) N0M0 or T1b (diameter 4 cm to 7 cm), solitary tumors should be performed robot-assited partial nephrectomy under

Sponsors

Jichi Medical University, Saitama Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. diagnosed with renal cell carcinoma and the clinical stage T1a (tumors less than 4 cm) N0M0 or T1b (diameter 4 cm to 7 cm), solitary tumors allows partial resection. 2. age of 20 years or more. 3. written informed consent obtained from the individual persons.

Exclusion criteria

Exclusion criteria: 1. the patient seems to be difficult to surgery due to previous surgery. 2. activity of heavy multiple cancer among patients. 3.6 months undergoing treatment for kidney cancer. 4. patients with possible discontinuation of anticoagulants. 5. patients requiring blood transfusion anemia or tendency of bleeding. 6. morbid obesity (BMI35 or higher) 7. kidney transplantation history. 8. dialysis patients. 9. pregnant women or pregnant or lactating women 10. patients with a mental illness or psychiatric symptoms. 11. patients have serious complications (angina pectoris, myocardial infarction, serious arrhythmias, uncontrolled diabetes, malignant hypertension, etc.), surgical treatment is difficult. 12. patients who have renal dysfunction (serum creatinine values:1.5mg/dl more), liver function (AST, ALT:100IU/l). 13. patients with bacterial infections require treatment. 14. patients with interstitial Pneumonitis or pulmonary fibrosis. 15. patients with severe drug hypersensitivity, drug allergies. 16. patients with under 20 years old. 17. patient deemed unfit for this protocol.

Design outcomes

Primary

MeasureTime frame
intra-and postoperative complications and its contents

Secondary

MeasureTime frame
Time of general anesthesia, operation time, bleeding, renal ischemic time, frequency of postoperative analgesic use, postoperative hospitalization period, perioperative renal function (before surgery (pre-operative surgery 12 weeks before),the day before surgery, on the day of the surgery, the day after surgery, the surgery three days after, the surgery six days later, after one month, three months after surgery)serum creatinine, eGFR), and before surgery (pre-operative surgery 12 weeks before), the day of one month, three months after surgery of renal scintigraphy), pathology findings

Countries

Japan

Contacts

Public ContactTomoaki Miyagawa

Jichi Medical University, Saitama Medical Center Department of Urology

sh2-mya@jichi.ac.jp048-647-2111

Outcome results

None listed

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