ISRCTN18156881
Active, not recruiting
未知
A feasibility study of a cohort embedded randomised controlled trial comparing NEphron-Sparing Treatment (NEST) for small renal masses
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Royal Free London NHS Foundation Trust
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31189686/ protocol (added 26/06/2020)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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