Off Clamp Randomization



Status:Active, not recruiting
Conditions:Cancer, Cancer, Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/31/2019
Start Date:November 2012
End Date:June 30, 2020

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Trial Summary
Trial Overview
Inclusion Criteria

Evaluation of the Off-Clamp Robot-Assisted Partial Nephrectomy Technique in the Management of Renal Tumors

The purpose of this research study is to compare the effects on kidney function after
performing the removal of a kidney tumor with or without clamping the blood vessels during
surgery.


Inclusion Criteria:

- Patients 18 and older.

- Patients willing and able to sign consent.

- Patients with an organ confined renal mass planning to undergo a robotic assisted
partial nephrectomy (RAPN).

- Patient with Karnofsky Performance Status (KPS) equal to or greater than 40.

Exclusion Criteria:

- Patients under 18.

- Patients with Karnofsky Performance Status (KPS) less than 40.

- Patients with non-organ confined renal masses (invading renal vein, inferior vena
cava, peri-renal tissue, ipsilateral adrenal gland, or metastasis).

- Patients with bilateral synchronous renal masses.

- Patients who can not discontinue Plavix, Coumadin or other anti-platelet or
anti-coagulant medications.

- Patients with renal lesions determined to be too complex to perform a RAPN without
clamp by the surgeon. (The renal mass may be deemed too difficult based on
pre-operatively radiological findings. The surgeon's decision to exclude a mass from a
robotic assisted partial nephrectomy would be based on a higher risk of positive
margin or complication if a RAPN was performed.)
We found this trial at
1
site
Washington University School of Medicine
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
397
mi
from 43215
Saint Louis, MO
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