Off Clamp Randomization
Renal Cancer - Renal Ischemia
Conditions: official terms
Carcinoma, Renal Cell - Kidney Neoplasms
Conditions: Keywords
off-clamp, partial nephrectomy, renal cancer treatment, renal ischemia
Study Type
Study Phase
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Name: Off-clamp partial nephrectomy
Type: Procedure
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.)
Washington University School of Medicine
St. Louis, Missouri, United States
Status: Recruiting
Start Date
November 2012
Completion Date
April 2020
Washington University School of Medicine
Washington University School of Medicine
Record processing date processed this data on July 28, 2015 page