cT1,cN0,cM0 Hilar Tumors
Conditions
Sponsors
Kobe University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The tumor is diagnosed as the mass located in the renal hilum in contact with a major renal vessels on preoperative imaging, either CT* abdomen scan or MRI (if the patient is unable to take the contrast agent) and an indication for partial nephrectomy. (*slice of contrast enhanced CT abdomen must be <5 mm) 2) The tumor is less than 7 cm (cT1) 3) Detecting no metastasis of lymph node or intra-abdominal organ by either contrast enhanced CT* abdomen scan or MRI (if the patient is unable to take the contrast agent). (cN0,cM0). 4) Detecting no metastasis by the contrast enhanced CT chest scan or bone scintigraphy. 5) Single tumor 6) The subject's laboratory test results wthin 12 weeks before registration are as follows -WBC > 3000/microL -Plt >= 10x10^4/microL -AST =< 100 IU/L -ALT =< 100 IU/L -Total Bilirubin =< 2.0 mg/dL -Serum creatinine =< 2.0 mg/dL 7)>= 20 years of age at the informed consent. 8)Written informed consent is obtained.
Exclusion criteria
Exclusion criteria: 1)multiple cancer 2)history of kidney transplantation. 3)therapies for renal cell cancer in the past 6 months. 4) Has a high risk to general anesthesia 5) unable to withdrawal of anticoagulation 6) anemia or hemorrhagic tendency requiring transfusion 7) obesity(Body Mass Index:BMI>=35) 8) dialysis patient. 9) pregnant, suspected of being pregnant, or lactating woman. 10) difficult to participate the study due to psychiatric disorder or psychological symptom. 11 )Judged as an inappropriate patient by the investigator or sub-investigator at the hospital (site) for any other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Warm ischemia time (min) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints - Margin negative - Warm ischemia time (within 25 min or not) - Achieved both margin negative and warm ischemia time (within 25 min) - Change of pre- and post- operative ERPF (mL/min) in operated kidney - Change of split (%) multiplied by eGFR in operated kidney - eGFR - Overall survival time - Recurrence-free survival time Safety Endpoints - Failure of DVSS - Adverse Events Other Endpoints - Operative Time - Console Time - Blood Loss - Conversion to open surgery or laparoscopic surgery | — |
Countries
Japan
Contacts
Public ContactNobuyuki Hinata
Kobe University Graduate School of Medicine Division of Urology, Department of Surgery Related
Outcome results
None listed