Journal article

Excisional treatment comparison for in situ endocervical adenocarcinoma (EXCISE): A phase 2 pilot randomized controlled trial to compare histopathological margin status, specimen size and fragmentation after loop electrosurgical excision procedure and cold knife cone biopsy

Paul A Cohen, Yee Leung, Lyndal Anderson, Rachael van der Griend, Paola Chivers, Sanela Bilic, Sophie Bittinger, Alison Brand, Max K Bulsara, Jim Codde, Lois Eva, Louise Farrell, Dianne Harker, Unine Herbst, Stephanie Jeffares, Diane Loh, Orla McNally, Ganendra Raj Mohan, Tarryn Nicholson, Aime Powell Show all

Gynecologic Oncology | ACADEMIC PRESS INC ELSEVIER SCIENCE | Published : 2020

Abstract

OBJECTIVE: Adenocarcinoma in situ (AIS) of the cervix is a precursor to cervical adenocarcinoma. When AIS is detected by cervical screening an excision biopsy is mandatory to exclude invasion. We aimed to compare margins status, specimen size and fragmentation after loop electrosurgical excision procedure (LEEP) and 'cold knife cone biopsy' (CKC). METHODS: The EXCISE Trial was an investigator-initiated, multicenter, open-label, parallel-group, phase 2, randomized study. Patients were enrolled at seven hospitals in Australia and New Zealand. We randomly assigned women aged ≥18 to ≤45 years with screen detected AIS to LEEP or CKC. Co-primary endpoints were margin status, specimen size and frag..

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Grants

Awarded by Australia New Zealand Gynaecological Oncology Group


Funding Acknowledgements

Australia New Zealand Gynaecological Oncology Group [#FNR2016/03].