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

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

Authors:	Leitao, M. M. Jr; Iasonos, A.; Tomberlin, M.; Moukarzel, L. A.; Price, H.; Bennetti, G.; Ramesh, B.; Chi, D. S.; Long Roche, K.; Sonoda, Y.; Al-Niami, A.; Mueller, J. J.; Gardner, G. J.; Broach, V.; Jewell, E. L.; Kim, S.; Feinberg, J.; Abu-Rustum, N. R.; Zivanovic, O.
Article Title:	ARIA II: A randomized controlled trial of near-infrared Angiography during RectosIgmoid resection and Anastomosis in women with ovarian cancer
Abstract:	Background 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.Primary Objective 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.Study Hypothesis 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.Trial Design 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.Major Inclusion/Exclusion Criteria 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.Primary Endpoint Rate of 30-day post-operative pelvic complications.Sample Size 310 (155 per arm)Estimated Dates for Completing Accrual and Presenting Results Q2 2027 and Q4 2027, respectively.Trial Registration NCT04878094.
Keywords:	ovarian cancer; complications; gynecologic surgical procedures; postoperative; impact; surgical oncology; primary debulking surgery
Journal Title:	International Journal of Gynecological Cancer
Volume:	34
Issue:	7
ISSN:	1048-891X
Publisher:	Lippincott Williams & Wilkins
Date Published:	2024-07-01
Start Page:	1098
End Page:	1101
Language:	English
ACCESSION:	WOS:001188996000001
DOI:	10.1136/ijgc-2024-005395
PROVIDER:	wos
PUBMED:	38514101
PMCID:	PMC11750067
Notes:	Article -- MSK author Ahmed Al-Niaimi's last name is misspelled on the original publication -- MSK corresponding author is Mario Leitao Jr -- Source: Wos