Ovarian Cancer, Ovarian Carcinoma
Conditions
Keywords
Ovarian cancer, PINPOINT, rectosigmoid resection, anastomosis, 21-202, Memorial Sloan Kettering Cancer Center
Brief 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.
Interventions
DIAGNOSTIC_TESTIntravenous Indocyanine Green/ICG injection
Intravenous Indocyanine Green/ICG injection will be administered for visualization
DIAGNOSTIC_TESTPINPOINT 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.
DIAGNOSTIC_TESTEndoscopy
Standard technique and assessment of anastomosis without the use of NIR angiography
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
Participant Inclusion Criteria Part 1 (pre-operative): * 18 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 Participant
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone | 45 days post procedure | To determine whether the use of NIR angiography assessment of perfusion at the time of rectosigmoid resection in a cohort of patients undergoing surgery for ovarian cancer reduces the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMario Leitao, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed