A Study of Intra-operative Imaging in Women With Ovarian Cancer
ARIA II: A Phase III Randomized Controlled Trial of Near-Infrared Angiography During Rectosigmoid Resection and Anastomosis in Women With Ovarian Cancer
About This Trial
The purpose of this study is to find out whether using the PINPOINT imaging system intra-operatively can reduce the risk of anastomotic leaks and other complications after surgery for ovarian cancer, compared with standard intra-operative assessments alone. The PINPOINT endoscopic fluorescence imaging system uses a special camera and a fluorescent (glowing) dye that can evaluate the blood flow of the bowel in real-time. If there is an area that appears concerning, the surgeon can correct the problem during the procedure.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
Intravenous Indocyanine Green/ICG injection
Intravenous Indocyanine Green/ICG injection will be administered for visualization
PINPOINT endoscopic fluorescence imaging system
After resection the surgeon will use the PINPOINT imaging system to assess perfusion of the colonic stump. The intervention will again be used following establishment of the anastomosis, however this time via a proctoscope to visualize the proximal and distal ends of the rectosigmoid anastomosis.
Endoscopy
Standard technique and assessment of anastomosis without the use of NIR angiography