Off Clamp Randomization
Conditions
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
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Intervention
Name: Off-clamp partial nephrectomy
Type: Procedure
Overall Status
Recruiting
Summary
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.)
Location
Washington University School of Medicine
St. Louis, Missouri, United States
Status: Recruiting
Start Date
November 2012
Completion Date
April 2020
Sponsors
Washington University School of Medicine
Source
Washington University School of Medicine
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page