跳至主要内容
临床试验/ISRCTN18156881
ISRCTN18156881进行中(未招募)未知

A feasibility study of a cohort embedded randomised controlled trial comparing NEphron-Sparing Treatment (NEST) for small renal masses

Royal Free London NHS Foundation Trust0 个研究点目标入组 200 人开始时间: 2019年3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)
入组人数
200

研究概览

简要总结

2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31189686/ protocol (added 26/06/2020)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • Inclusion criteria for study cohort:
  • 1. Informed consent
  • 2. Males and females
  • 3. > 18 years of age
  • 4. Diagnosed with renal mass <4 cm in size
  • Inclusion criteria for randomisation/interventional cohort:
  • 1. Biopsy proven RCC
  • 2. Tumours that are suitable for robot-assisted PN and CO

排除标准

  • Exclusion criteria for study cohort:
  • 1. Any of the above listed inclusion criteria not met
  • 2. Patient unable to provide or indicate informed consent
  • Exclusion criteria for randomisation/interventional cohort:
  • Patients with any concurrent medical/surgical condition or indication, which would mean the SMDT recommends one treatment modality is more suitable than another, such as:
  • 1. Myocardial Infarction in preceding 6/12
  • 2. Pulmonary disease not allowing for prolonged anaesthesia
  • 3. Multiple previous abdominal surgery/interventions, making surgical approach high risk
  • 4. Performance status > = 2
  • 5. Metastatic disease
  • 6. Charlson co-morbidity index > 3
  • 7. Patients with multifocal tumours
  • 8. Patients with suspected or diagnosed with inherited kidney cancer susceptibility syndromes
  • 9. Women that are pregnant or breastfeeding

研究者

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