Off Clamp Randomization

Washington University School of Medicine80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Renal Cancer Renal Ischemia

Interventions

Off-clamp partial nephrectomyPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.)

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Percent Change From Baseline in eGFR

Renal function following nephrectomy with and without clamping will be assessed using: percent change in eGFR from baseline to 3 months post nephrectomy.

Time frame: baseline and 3 months post nephrectomy

Percent Change From Baseline in Split Renal Function

Renal function following nephrectomy with and without clamping will be assessed using: percent change in split renal function from baseline to 3 months post nephrectomy.

Time frame: baseline to 3 months post nephrectomy

Secondary Outcomes

Percent of Observations With Positive Surgical Margins.

Oncologic outcomes will be assessed at the time of nephrectomy based on percent of observations with positive surgical margins.

Time frame: at the time of nephrectomy

Estimated Blood Loss

Perioperative outcomes will be assessed based on estimated blood loss at the time of nephrectomy.

Time frame: At the time of nephrectomy

Percent of Observations With Metastasis

Oncologic outcomes will be assessed based on percent of observations with metastasis on follow-up imaging at 3 years post nephrectomy.

Time frame: 3 years

Operative Time Measured in Minutes.

Perioperative outcomes will be assessed based on operative time measured in minutes at the time of nephrectomy.

Time frame: At the time of nephrectomy

Warm Ischemia Time Measured in Minutes.

Perioperative outcomes will be assessed based on warm ischemia time measured in minutes at the time of nephrectomy.

Data from ClinicalTrials.gov

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