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Study of Intra-operative Imaging in Women with Ovarian Cancer
Trial Status: active
This phase III trial evaluates whether using the PINPOINT endoscopic fluorescence imaging system to check the connected bowel for blood flow during surgery (intra-operatively) for ovarian cancer may reduce the occurrence of anastomotic leaks and the need for additional procedures, compared with standard intra-operative assessments alone. The usual approach to the surgical treatment of ovarian cancer may include procedures called rectosigmoid resection and anastomosis in order to remove the disease. A known and serious complication of this procedure is an anastomotic leak, in which partially digested food and other fluids leak from the newly connected section of the bowel. If a leak is identified after surgery, it may or may not require additional surgery to treat this complication. The PINPOINT endoscopic fluorescence imaging system uses a special (near-infrared [NIR]) camera and a fluorescent (glowing) dye called ICG (indocyanine green) to help evaluate the blood supply of the bowel during surgery. If there is an area that appears concerning, the surgeon can correct the problem during the procedure. Using the PINPOINT imaging system intra-operatively may reduce the risk of anastomotic leaks and other complications after surgery for ovarian cancer, compared with standard intra-operative assessments alone.
Inclusion Criteria
PART 1 (PRE-OPERATIVE): 18 years or older
PART 1 (PRE-OPERATIVE): Diagnosed with primary or recurrent ovarian, fallopian tube, or primary peritoneal cancer
PART 1 (PRE-OPERATIVE): Scheduled to undergo debulking or cytoreductive surgery
PART 1 (PRE-OPERATIVE): Suspected need for a low anterior rectosigmoid resection at the time of a debulking procedure
PART 1 (PRE-OPERATIVE): Enrolled and consented before the operation
PART 2 (INTRA-OPERATIVE): Completed rectosigmoid resection
PART 2 (INTRA-OPERATIVE): Surgeon plans to perform colorectal anastomosis
Exclusion Criteria
PART 1 (PRE-OPERATIVE): Documented history of allergic reaction to indocyanine green (ICG)
PART 1 (PRE-OPERATIVE): Not approached for study enrollment before undergoing an unexpected low anterior rectosigmoid resection
PART 2 (INTRA-OPERATIVE): Did not undergo rectosigmoid resection intraoperatively
PART 2 (INTRA-OPERATIVE): Surgical procedure with rectosigmoid resection for any other type of gynecologic malignancy
PART 2 (INTRA-OPERATIVE): Patient requires permanent colostomy
Additional locations may be listed on ClinicalTrials.gov for NCT04878094.
I. To determine whether the use of near-infrared (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 resectionpelvic complications, including abscesses, anastomotic leaks, and infections, compared with standard intraoperative assessment alone.
SECONDARY OBJECTIVE:
I. To determine the impact of NIR angiography assessment of perfusion at the time of rectosigmoid resection for ovarian cancer on rates of diverting ostomies, NIR perfusion associated changes in management, intraoperative complications, postoperative anastomic leak, and 30-day readmissions.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo surgery per standard of care.
ARM B: Patients undergo surgery per standard of care. Patients also receive indocyanine green intravenously (IV) and undergo NIR angiography assessment using the PINPOINT imaging system during surgery.
After completion of study intervention, patients are followed up within 30-45 days.
Trial PhasePhase III
Trial Typediagnostic
Lead OrganizationMemorial Sloan Kettering Cancer Center
