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Clinical trial
ARIA II: a randomized controlled trial of near-infrared Angiography during RectosIgmoid resection and Anastomosis in women with ovarian cancer
  1. Mario M Leitao, Jr1,2,
  2. Alexia Iasonos3,
  3. Morgan Tomberlin1,
  4. Lea A Moukarzel1,
  5. Hannah Price1,
  6. Gabrielle Bennetti1,
  7. Bhavani Ramesh1,
  8. Dennis S Chi1,2,
  9. Kara Long Roche1,2,
  10. Yukio Sonoda1,2,
  11. Ahmed Al-Niami1,2,
  12. Jennifer J Mueller1,2,
  13. Ginger J Gardner1,2,
  14. Vance Broach1,2,
  15. Elizabeth L Jewell1,2,
  16. Sarah Kim1,2,
  17. Jacqueline Feinberg1,2,
  18. Nadeem R Abu-Rustum1,2 and
  19. Oliver Zivanovic1,2
    1. 1 Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA
    2. 2 Department of OB/GYN, Weill Cornell Medical College of Cornell University, New York, New York, USA
    3. 3 Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York, USA
    1. Correspondence to Dr Mario M Leitao, Jr, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, USA; leitaom{at}mskcc.org

    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.

    • Gynecologic Surgical Procedures
    • Ovarian Cancer
    • Postoperative complications
    • Surgical Oncology

    https://doi.org/10.1136/ijgc-2024-005395

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      Footnotes

      • Twitter @leitaomd, @VanceBroach, @jackiefeinberg

      • Contributors Conceptualization: ML, OZ. Data curation: MT, HP, GB, BR. Formal analysis: ML, OZ, AI. Methodology: OZ, AI. Roles/writing - original draft: ML, OZ. Writing - review and editing: all authors. Guarantor: ML.

      • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

      • Competing interests Dr Leitao reports personal fees from Medtronic, Intuitive Surgical, J&J/Ethicon, and Immunogen. Dr Abu-Rustum reports research funding paid to the institution from GRAIL. Memorial Sloan Kettering Cancer Center also has equity in GRAIL. Dr Chi reports personal fees from AstraZeneca, UptoDate, Biom’Up, Apyx Medical Corp, and Verthemia, as well as stock ownership in Doximity.

      • Provenance and peer review Not commissioned; internally peer reviewed.