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Clinical Trials/ISRCTN18156881
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

Royal Free London NHS Foundation Trust0 sites200 target enrollmentMarch 4, 2019

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)

Registry
who.int
Start Date
March 4, 2019
End Date
June 17, 2023
Last Updated
3 years ago
Study Type
Interventional
Sex
All

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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