More than 300,000 gastrointestinal resection and anastomosis per year are performed in the U.S. alone. Dehiscence or leakage from anastomotic sites following surgery occurs in 5-15% of patients and is associated with significant post-operative morbidity and mortality. Prior preclinical investigations have shown the importance of adequate tissue oxygenation at the anastomosis in preventing post-operative leakage and complications. Surgeons traditionally assess tissue viability and blood supply by simple visual inspection only. A method to assess anastomotic tissue viability intraoperatively would help perform corrective measures and improve surgical outcomes. We hypothesize that real-time monitoring of tissue oxygenation by wireless pulse oximetry (WiPOX) device provides a reliable, objective measure of tissue perfusion, and can detect tissue ischemia earlier than visual inspection, thereby allowing corrective actions to reduce post-operative morbidity and mortality. Our engineering (CCNY) and surgical (MSKCC) teams collaborated to develop and validate an innovative WiPOX device - this hand-held device and miniature probe provides operating surgeons with real-time, accurate, and convenient monitoring of the tissue oxygenation. This will not only enable the surgeon to monitor vascular compromise in real time in order to rectify any conduit twisting, but will also allow the surgeon to confidently select the site of maximal oxygenation for the anastomosis. This proposal will include pivotal device development and validation steps in three clinical applications (Aims): 1) Using a WiPOX model already validated in pilot clinical trials, we will conduct a prospective clinical trial of patients undergoing esophagogastrectomy, testing whether WiPOX can (a) predict anastomotic leaks resulting from tissue oxygenation (Ti02) compromise, and (b) optimize peri-anastomotic Ti02, thereby decrease post-operative anastomotic leakage. 2) To develop and test a new WiPOX model to detect early flap ischemia in patients undergoing microvascular free tissue transfer for breast reconstruction and conduct a pilot clinical trial. 3) Develop a new platform based on a multi-sensor array embedded in mesh to envelope a liver or heart and test the device in large animals for detecting real-time intraoperative blood flow compromise during liver resections and heart bypass surgery.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Specialized Center--Cooperative Agreements (U54)
Project #
2U54CA132378-06
Application #
8744947
Study Section
Special Emphasis Panel (ZCA1-SRLB-Y (O1))
Project Start
2013-09-25
Project End
2018-08-31
Budget Start
2013-09-25
Budget End
2014-08-31
Support Year
6
Fiscal Year
2013
Total Cost
$166,610
Indirect Cost
$64,577
Name
City College of New York
Department
Type
DUNS #
603503991
City
New York
State
NY
Country
United States
Zip Code
10031
Yeh, Yi-Chen; Nitadori, Jun-ichi; Kadota, Kyuichi et al. (2015) Using frozen section to identify histological patterns in stage I lung adenocarcinoma of ? 3 cm: accuracy and interobserver agreement. Histopathology 66:922-38
Shen, Megan Johnson; Binz-Scharf, Maria; D'Agostino, Tom et al. (2015) A mixed-methods examination of communication between oncologists and primary care providers among primary care physicians in underserved communities. Cancer 121:908-15
Lubetkin, Erica I; Zabor, Emily C; Brennessel, Debra et al. (2014) Beyond demographics: differences in patient activation across new immigrant, diverse language subgroups. J Community Health 39:40-9
Kadota, Kyuichi; Yeh, Yi-Chen; Sima, Camelia S et al. (2014) The cribriform pattern identifies a subset of acinar predominant tumors with poor prognosis in patients with stage I lung adenocarcinoma: a conceptual proposal to classify cribriform predominant tumors as a distinct histologic subtype. Mod Pathol 27:690-700
Li, Guang; Caraveo, Marshall; Wei, Jie et al. (2014) Rapid estimation of 4DCT motion-artifact severity based on 1D breathing-surrogate periodicity. Med Phys 41:111717
Kachala, Stefan S; Bograd, Adam J; Villena-Vargas, Jonathan et al. (2014) Mesothelin overexpression is a marker of tumor aggressiveness and is associated with reduced recurrence-free and overall survival in early-stage lung adenocarcinoma. Clin Cancer Res 20:1020-8
Qazi, Henry; Palomino, Rocio; Shi, Zhong-Dong et al. (2013) Cancer cell glycocalyx mediates mechanotransduction and flow-regulated invasion. Integr Biol (Camb) 5:1334-43
Nitadori, Jun-ichi; Colovos, Christos; Kadota, Kyuichi et al. (2013) Visceral pleural invasion does not affect recurrence or overall survival among patients with lung adenocarcinoma ýýý 2 cm: a proposal to reclassify T1 lung adenocarcinoma. Chest 144:1622-31
Silberstein, Jonathan L; Sprenkle, Preston C; Su, Daniel et al. (2013) Neutrophil gelatinase-associated lipocalin (NGAL) levels in response to unilateral renal ischaemia in a novel pilot two-kidney porcine model. BJU Int 112:517-25
Mandelblatt, Jeanne S; Hurria, Arti; McDonald, Brenna C et al. (2013) Cognitive effects of cancer and its treatments at the intersection of aging: what do we know; what do we need to know? Semin Oncol 40:709-25

Showing the most recent 10 out of 26 publications