Clinical trial NCT01931462: Microwave Coagulation in Partial Nephrectomy Protocol
Official title: A Single Arm Phase 1 Study of Microwave Coagulation Using 2450-MHz Antennae and CO2 Cooling in Partial Nephrectomy for T1 Renal Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer of Kidney
Keywords: Cancer of the Kidney
Renal Cancer
Renal Neoplasms
Neoplasms, Kidney
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2013-08-29
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Patient must have a solitary, polar, clinical T1 renal mass
2. 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.
3. Women of child-bearing potential must have negative serum or urine pregnancy test
4. Patient must be able to give written informed consent
5. Patient must be 18 years or older
6. No blood-thinning medications, including anti-inflammatory medications, herbs and supplements for at least 1 week prior to surgery

Exclusion Criteria:

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

Primary outcomes:
measure: 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.
timeFrame: 30 days prior to surgery (Baseline) and 6 weeks post surgery
Secondary outcomes:
measure: Blood Loss
timeFrame: During the operation
measure: Operative Time
timeFrame: During the operation
measure: Clamp Time
timeFrame: During the operation
measure: Change in Renal Function
timeFrame: Within 30 days prior to operation and 6 weeks post operation
measure: Change in Functional Renal Volume
timeFrame: Within 30 days prior to operation and 6 weeks post-operation
measure: Tumor Margin
timeFrame: During the operation and 6 weeks post-operation
measure: Complication Rates
timeFrame: During the operation
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: E Jason Abel, MD
role: PRINCIPAL_INVESTIGATOR
References: