Off Clamp Randomization

Study Overview
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Brief Summary
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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.

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

Conditions
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Renal Cancer, Renal Ischemia

Intervention / Treatment
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* Procedure: Off-clamp partial nephrectomy


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Off-clamp partial nephrectomy<br>Partial nephrectomy will be performed without clamping of the renal blood vessels. | Procedure: Off-clamp partial nephrectomy<br> <br> |
| No Intervention: Traditional partial nephrectomy<br>Partial nephrectomy will be performed with clamping of the renal blood vessels. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | baseline to 3 months post nephrectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at the time of nephrectomy | 
| Estimated Blood Loss | Perioperative outcomes will be assessed based on estimated blood loss at the time of nephrectomy. | 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. | 3 years | 
| Operative Time Measured in Minutes. | Perioperative outcomes will be assessed based on operative time measured in minutes at the time of nephrectomy. | 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. | At the time of nephrectomy. | 
| Percent of Observations With Intra-operative Complications. | Perioperative outcomes will be assessed based on percent of observations with intra-operative complications at the time of nephrectomy. | At the time of nephrectomy | 
| Number of Hospital Days Post Nephrectomy. | Perioperative outcomes will be assessed based number of hospital days post nephrectomy. | Day of nephrectomy to day of hospital discharge. | 
| Percent of Observations With Postoperative Complications. | Perioperative outcomes will be assessed based on percent of observations with postoperative complications. | Within 3 months post nephrectomy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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off-clamp, partial nephrectomy, renal cancer treatment, renal ischemia