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


N/A
18 Years
N/A
Open (Enrolling)
Both
Renal Cancer, Renal Ischemia

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Trial Information

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


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 aspirin, 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.)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Renal function

Outcome Description:

Renal function following nephrectomy with and without clamping will be assessed using: decline in estimated glomerular filtration rate decline in split renal function

Outcome Time Frame:

3 months post nephrectomy

Safety Issue:

No

Principal Investigator

Robert S Figenshau, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

myIRB ID 201208091

NCT ID:

NCT01732120

Start Date:

November 2012

Completion Date:

April 2020

Related Keywords:

  • Renal Cancer
  • Renal Ischemia
  • off-clamp
  • partial nephrectomy
  • renal cancer treatment
  • renal ischemia
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Ischemia

Name

Location

Washington University School of Medicine Saint Louis, Missouri  63110