JPRN-jRCT1052190005
Active, not recruiting
未知
n-blinded Multicenter Study to Assess the Safety of Robotic-assisted (da Vinci surgical system, DVSS) Laparoscopic Partial Nephrectomy for Hilar Tumors
Masato Fujisawa0 sites108 target enrollmentApril 4, 2019
ConditionscT1,cN0,cM0 Hilar Tumors
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- cT1,cN0,cM0 Hilar Tumors
- Sponsor
- Masato Fujisawa
- Enrollment
- 108
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 within 12 weeks before registration are as follows
- •\- WBC \>\= 3000/microL
- •\- Plt \>\= 10 x 10^4/microL
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.
Outcomes
Primary Outcomes
Not specified
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