Approximately 54,000 Americans are diagnosed with renal cell carcinoma each year. The disease kills about 14,000 Americans each year and has the highest mortality rate of all urologic cancers (about twice the mortality rate of prostate and bladder cancer). In the past, treatment of renal cell carcinoma required surgical removal of the entire affected kidney leaving the patient at life-long risk for developing renal insufficiency or complete loss of renal function if their remaining kidney was compromised for any reason. Fortunately, recent advances in imaging have dramatically increased detection of small tumors that are amenable to local resection. As a result, surgical resection of only that portion of the kidney containing the tumor (partial nephrectomy) has become the preferred approach in many patients. This transition to less aggressive surgery has been accompanied by increased reliance on minimally-invasive, laparoscopic surgery. However, laparoscopic kidney surgery is technically demanding, primarily due to difficulties in visualizing tumor margins and navigating around anatomic structures imposed by current laparoscopic tools. As a result, the rate of significant complications (including vascular injuries and failure to obtain clear surgical margins) remains higher in laparoscopic partial nephrectomy than in comparable open procedures. The goal of this project is development of a system enabling renal surgeons to use methods previously developed for image-guided neurosurgery during laparoscopic resection of kidney lesions. These methods allow the margins of key anatomic structures (e.g., tumors, vessels, and ducts) to be superimposed onto the laparoscopic video images. During Phase I, we built a laparoscopic instrument capable of measuring the position and shape of the renal capsule during surgery. During Phase II, we will build a second-generation refined system and will evaluate the performance of the system in a series of animal experiments. We have assembled a highly qualified team for this project. The lead Creare engineers have experience in the development of laparoscopic technology and development of novel medical imaging technology. Our team also includes prominent surgeons with expertise in laparoscopic surgery, and biomedical engineers who have been pioneers in the development of image-guided surgery.

Public Health Relevance

The goal of this project is development of a new technology to assist surgical navigation as a means of reducing complication rates and improving the outcomes of laparoscopic kidney surgery. Laparoscopic partial nephrectomy is a commonly performed procedure that offers tremendous benefits to the patient. Unfortunately, the risk of serious complications in this laparoscopic procedure remains higher than in conventional open surgery.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44DK081240-04
Application #
8246961
Study Section
Special Emphasis Panel (ZRG1-DKUS-K (11))
Program Officer
Kirkali, Ziya
Project Start
2008-04-01
Project End
2015-03-31
Budget Start
2012-04-01
Budget End
2015-03-31
Support Year
4
Fiscal Year
2012
Total Cost
$254,511
Indirect Cost
Name
Creare, Inc.
Department
Type
DUNS #
072021041
City
Hanover
State
NH
Country
United States
Zip Code
03755