Microwave Coagulation in Partial Nephrectomy Protocol
| Status: | Terminated |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/24/2018 |
| Start Date: | August 2014 |
| End Date: | December 2016 |
A Single Arm Phase 1 Study of Microwave Coagulation Using 2450-MHz Antennae and CO2 Cooling in Partial Nephrectomy for T1 Renal Tumors
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.
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.
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
We found this trial at
1
site
Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: E Jason Abel, MD
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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