JPRN-jRCT1052190004
Active, not recruiting
未知
n-blinded Multicenter Study to Assess the Safety and Efficacy of Robotic-assisted (da Vinci surgical system, DVSS) Laparoscopic Partial Nephrectomy for Renal Cell Carcinoma Patients
Masato Fujisawa0 sites100 target enrollmentApril 4, 2019
ConditionscT1 Renal Cancer
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- cT1 Renal Cancer
- Sponsor
- Masato Fujisawa
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)cT1 renal cell carcinoma clinically diagnosed by contrast enhanced CT abdomen scan (if the patient is unable to take the contrast agent, MRI will be performed), and a partial nephrectomy is able to be performed.
- •(slice of contrast enhanced CT abdomen must be \<1 cm)
- •2\)detecting no metastasis of lymph node or intra\-abdominal organ by contrast enhanced CT abdomen scan (if the patient is unable to take the contrast agent, MRI will be performed) (cN0,cM0\).
- •3\)detecting no metastasis by the contrast enhanced CT chest scan or bone scintigraphy.
- •4\)single tumor
- •5\)Tested within 6 weeks (42 days) prior to enrollment.
- •\-WBC \> 3000/microL
- •\-Plt \>\= 10x10^4/microL
- •\-AST \=\< 100 IU/L
- •\-ALT \=\< 100 IU/L
Exclusion Criteria
- •1\)multiple cancer
- •2\)history of kidney transplantation
- •3\)therapies for renal cell cancer in the past 6 months
- •4\)unable to withdrawal of anticoagulation
- •5\)anemia or hemorrhagic tendency requiring transfusion
- •6\)obesity (Body Mass Index: BMI\>\=35\)
- •7\)dialysis patient
- •8\)pregnant, suspected of being pregnant, or lactating woman
- •9\)difficult to participate the study due to psychiatric disorder or psychological symptom
- •10\)inappropriate by the investigator or sub\-investigator at the hospital (site) for any other reasons
Outcomes
Primary Outcomes
Not specified
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