Off Clamp Randomization

The Washington University

Status

Completed

Conditions

Renal Ischemia

Renal Cancer

Treatments

Procedure: Off-clamp partial nephrectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01732120

myIRB ID 201208091

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.)