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 个研究点目标入组 100 人开始时间: 2019年4月4日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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
•-Total Bilirubin =< 2.0 mg/dL
•-Serum creatinine =< 2.0 mg/dL
•6)>= 20 years of age at the informed consent.
•7)written informed consent is obtained.

•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

发起方

Masato Fujisawa