Evidence map›Paper›PMID 38514101›Full record

ArticleInternational journal of gynecological cancer : official journal of the International Gynecological Cancer Society2024

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

Mario M Leitao, Alexia Iasonos, Morgan Tomberlin, Lea A Moukarzel, Hannah Price, Gabrielle Bennetti, Bhavani Ramesh, Dennis S Chi, Kara Long Roche, Yukio Sonoda and 9 more

Registry-linked trialOpen access · greenAbstract readClinical Trial Protocol
In one paragraph

Article in International journal of gynecological cancer : official journal of the International Gynecological Cancer Society, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04878094 (ARIA II), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.1field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04878094 phase3active not recruitingnot on this map

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

TypeinterventionalSponsorMemorial Sloan Kettering Cancer CenterRan2021 to 2027Enrolled155ConditionsOvarian Cancer, Ovarian CarcinomaArmsIntravenous Indocyanine Green/ICG injection, PINPOINT endoscopic fluorescence imaging system, Endoscopy
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 1 institution in 1 country.

Mario M LeitaoDepartment of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA leitaom@mskcc.org.ORCID 0000-0003-0818-3836
Alexia IasonosDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Morgan TomberlinDepartment of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Lea A MoukarzelDepartment of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Hannah PriceDepartment of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Gabrielle BennettiDepartment of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Bhavani RameshDepartment of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Dennis S ChiDepartment of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA.ORCID 0000-0002-3105-8913
Kara Long RocheDepartment of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Yukio SonodaDepartment of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Ahmed Al-NiamiDepartment of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Jennifer J MuellerDepartment of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA.ORCID 0000-0003-0365-7510
Ginger J GardnerDepartment of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA.ORCID 0000-0003-3955-3238
Vance BroachDepartment of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Elizabeth L JewellDepartment of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA.ORCID 0000-0001-7563-7610
Sarah KimDepartment of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Jacqueline FeinbergDepartment of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Nadeem R Abu-RustumDepartment of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA.ORCID 0000-0001-9689-1298
Oliver ZivanovicDepartment of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Memorial Sloan Kettering Cancer Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundOvarian 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

objectiveTo 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

designThis 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

resultsQ2 2027 and Q4 2027, respectively.

trial registrationNCT04878094.

Indexed as

Anastomosis, SurgicalOvarian NeoplasmsAngiographyColon, SigmoidCytoreduction Surgical ProceduresFemaleHumansIndocyanine GreenPostoperative ComplicationsRandomized Controlled Trials as TopicRectumSpectroscopy, Near-InfraredIndocyanine GreenGynecologic Surgical ProceduresOvarian CancerPostoperative complicationsSurgical Oncology

Identifiers

PMID38514101
PMCPMC11750067
OpenAlexW4393033303

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.