A Study of Intra-operative Imaging in Women With Ovarian Cancer

NCT04878094RecruitingPHASE3INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

310

Start Date

2021-05-03

Completion Date

2026-05-03

Study Type

INTERVENTIONAL

Official Title

ARIA II: A Phase III Randomized Controlled Trial of Near-Infrared Angiography During Rectosigmoid Resection and Anastomosis in Women With Ovarian Cancer

Interventions

Intravenous Indocyanine Green/ICG injectionPINPOINT endoscopic fluorescence imaging systemEndoscopy

Conditions

Ovarian CancerOvarian Carcinoma

Eligibility

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Reduction of the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone

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.

Time frame: 45 days post procedure

Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, United States

Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities), Commack, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, United States

Jefferson Abington Hospital, Willow Grove, United States

Houston Methodist Cancer Center (Data Collection Only), Houston, United States

Linked Papers

2024-07-01

ARIA II: a randomized controlled trial of near-infrared Angiography during RectosIgmoid resection and Anastomosis in women with ovarian cancer

Ovarian cancer with extensive metastatic disease involving pelvic structures often requires rectosigmoid resection for complete gross resection; however, it is associated with increased surgical morbidity. There are limited data, and none in ovarian cancer, on near-infrared assessment of perfusion in rectosigmoid resections with anastomosis. To compare the rate of pelvic complications (pelvic abscesses, anastomotic leaks, and infections) within 30 days of surgery with and without near-infrared assessment of perfusion at time of rectosigmoid resection and re-anastomosis in patients undergoing cytoreductive surgery for ovarian cancer. We hypothesize the use of near-infrared technology (intravenous indocyanine green and endoscopic near-infrared fluorescence imaging), compared with standard intra-operative assessment, to evaluate anastomotic perfusion at time of rectosigmoid resection and re-anastomosis will result in lower rates of post-operative pelvic complications. This is a planned multicenter randomized controlled trial. Patients who undergo rectosigmoid resection as part of their ovarian cytoreductive surgery will be randomized 1:1 to standard assessment of anastomosis with the surgeon's usual technique (control arm) or assessment with near-infrared angiography using indocyanine green and endoscopic fluorescence imaging (experimental arm). Randomization will occur after rectosigmoid resection has been completed and the surgeon declares their plan to create a diverting ostomy. Randomization will be stratified by plan for diverting ostomy. Main inclusion criteria include patients with primary or recurrent ovarian, fallopian tube, or primary peritoneal cancer who are scheduled for cytoreductive surgery with suspected need for low-anterior rectosigmoid resection. Rate of 30-day post-operative pelvic complications. 310 (155 per arm) ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Q2 2027 and Q4 2027, respectively. NCT04878094.