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临床试验/JPRN-jRCT1052190004
JPRN-jRCT1052190004进行中(未招募)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 个研究点目标入组 100 人开始时间: 2019年4月4日最近更新:
适应症

试验速览

阶段
未知
状态
进行中(未招募)
发起方
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 20age old 至 ot applicable(—)
性别
All

入选标准

  • 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.

排除标准

  • 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

研究者

发起方
Masato Fujisawa

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