Microwave Coagulation in Partial Nephrectomy Protocol

Not Applicable

Terminated

Conditions: Cancer of Kidney

Interventions: Device: Microwave pre-coagulation

Registration Number: NCT01931462

Lead Sponsor: University of Wisconsin, Madison

Brief Summary: Partial nephrectomy (kidney removal) is a standard therapy for clinical T1 renal (kidney) tumors. The goals of surgery are to accurately remove the tumor with no cancer cells at the edge of the remaining tissue, to limit blood loss, and preserve kidney function. The most common technique is to clamp the blood supply to the entire kidney during removal and to surgically repair the tumor bed with suture and agents to stop bleeding. This stops the blood supply to the entire kidney including the healthy tissue, which can cause damage to the remaining tissue due to a shortage of oxygen if left clamped too long.

This study uses a microwave pre-coagulation technique using the Certus 140™ to facilitate a bloodless area near the tumor for accurate tumor removal and repair, while avoiding clamping the blood supply, but its effect on the function of kidney adjacent to tumor is unknown. If adequate stoppage of bleeding is achieved using the Certus 140™ with minimal heat spreading to the remaining tissue, clamping and a shortage of oxygen can be avoided.

The hypothesis is that microwave pre-coagulation is a safe method for providing the stoppage of bleeding during partial kidney removal.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 2

Inclusion Criteria

Patient must have a solitary, polar, clinical T1 renal mass
Patient must have adequate kidney function as measured by eGFR (estimated glomerular filtration rate) greater than or equal to 50 calculated from a standard care serum creatinine performed within 30 days prior to the partial nephrectomy operation.
Women of child-bearing potential must have negative serum or urine pregnancy test
Patient must be able to give written informed consent
Patient must be 18 years or older
No blood-thinning medications, including anti-inflammatory medications, herbs and supplements for at least 1 week prior to surgery

Exclusion Criteria

T stage greater than clinical T1
Tumor extends beyond kidney into major veins, perinephric tissues, or adrenal gland
Prior surgery or radiation therapy to the region of interest
Patient has a single functioning kidney
Patient has an uncorrectable coagulopathy
Patient is not a surgical candidate due to underlying cardiac or other serious comorbid condition

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Certus 140™	Microwave pre-coagulation	During the operation: use of Certus 140™ microwave device for pre-coagulation of the kidney tissue adjacent to the tumor.

Primary Outcome Measures

Name	Time	Method
To Assess the Effectiveness of Microwave Pre-coagulation Using the Certus 140™ System for Partial Nephrectomy on Renal Function Using the Estimated Glomerular Filtration Rate.	30 days prior to surgery (Baseline) and 6 weeks post surgery	We will be measuring the change in renal function as quantified by pre- and post-surgical estimated Glomerular Filtration Rate. Change = (6 week score - Baseline score)

Secondary Outcome Measures

Name	Time	Method
Clamp Time	During the operation	To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring clamp time. We will calculate the mean, median, standard deviation, and range of values for clamp time.
Change in Functional Renal Volume	Within 30 days prior to operation and 6 weeks post-operation	To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring the change in functional renal volume as measured by MRI. We will calculate the mean, median, standard deviation, and range of values for change in functional renal volume as measured by MRI.
Tumor Margin	During the operation and 6 weeks post-operation	The percentage of subjects with tumor positive margins will be reported. Tissue pathology will occur during the operation and a final tissue pathology will be performed 6 weeks after the operation.
Complication Rates	During the operation	Complication rates will be estimated using the methods of Kaplan and Meier.
Blood Loss	During the operation	To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring blood loss. We will calculate the mean, median, standard deviation, and range of values for blood loss.
Operative Time	During the operation	To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring operative time. We will calculate the mean, median, standard deviation, and range of values for operative time.
Change in Renal Function	Within 30 days prior to operation and 6 weeks post operation	To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring the change in renal function by nuclear scan and creatinine clearance. We will calculate the mean, median, standard deviation, and range of values for change in renal function by nuclear scan and creatinine clearance.