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
Memorial Sloan Kettering Cancer Center
310 participants
May 3, 2021
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- Part 1 (pre-operative):
- years or older
- Diagnosed with primary or recurrent ovarian, fallopian tube, or primary peritoneal cancer
- Scheduled to undergo debulking or cytoreductive surgery
- Suspected need for a low anterior rectosigmoid resection at the time of a debulking procedure
- Enrolled and consented before the operation
- Part 2 (intra-operative):
- Completed rectosigmoid resection
- Surgeon plans to perform colorectal anastomosis
Exclusion Criteria7
- Part 1 (pre-operative):
- Documented history of allergic reaction to ICG
- Not approached for study enrollment before undergoing an unexpected low anterior rectosigmoid resection
- Part 2 (intra-operative):
- Did not undergo rectosigmoid resection intraoperatively
- Surgical procedure with rectosigmoid resection for any other type of gynecologic malignancy
- Patient requires permanent colostomy
Interventions
Intravenous Indocyanine Green/ICG injection will be administered for visualization
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.
Standard technique and assessment of anastomosis without the use of NIR angiography
Locations(9)
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NCT04878094