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Obstetrics and gynaecology
Protocol
Excisional treatment in women with cervical adenocarcinoma in situ (AIS): a prospective randomised controlled non-inferiority trial to compare AIS persistence/recurrence after loop electrosurgical excision procedure with cold knife cone biopsy: protocol for a pilot study
  1. Paul A Cohen1,2,3,
  2. Alison Brand4,
  3. Peter Sykes5,6,
  4. David C H Wrede7,8,9,
  5. Orla McNally10,11,
  6. Lois Eva12,13,
  7. Archana Rao14,15,
  8. Michael Campion16,17,
  9. Martin Stockler18,19,
  10. Aime Powell20,
  11. Jim Codde21,
  12. Max K Bulsara22,
  13. Lyndal Anderson23,24,
  14. Yee Leung25,26,27,28,
  15. Louise Farrell29,
  16. Pennie Stoyles30
  1. 1 Division of Women’s and Infants’ Health, School of Medicine, University of Western Australia, Crawley, Western Australia, Australia
  2. 2 Department of Gynaecological Oncology, King Edward Memorial Hospital for Women, Subiaco, Western Australia, Australia
  3. 3 Department of Gynaecological Oncology, St John of God Hospital Bendat Family Comprehensive Cancer Centre, Subiaco, Western Australia, Australia
  4. 4 Department of Gynaecological Oncology, University of Sydney, Sydney, New South Wales, Australia
  5. 5 Department of Obstetrics and Gynaecology, Christchurch Women’s Hospital, Christchurch, Otago, New Zealand
  6. 6 Department of Obstetrics and Gynaecology, University of Otago, Christchurch, New Zealand
  7. 7 Department of Obstetrics and Gynaecology, Obstetrics and Gynaecology Consulting Group, Melbourne, Victoria, Australia
  8. 8 Gynaecological Cancer Centre, The Royal Women’s Hospital, Melbourne, Victoria, Australia
  9. 9 Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria, Australia
  10. 10 Department of Gynaecological Oncology, Victorian Comprehensive Cancer Centre, Melbourne, Victoria, Australia
  11. 11 Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria, Australia
  12. 12 Department of Gynaecological Oncology, National Women’s Health, Auckland City Hospital, Auckland, New Zealand
  13. 13 Department of Gynaecological Oncology, University of Auckland, Auckland, New Zealand
  14. 14 Department of Gynaecological Oncology, Royal Hospital for Women, Randwick, New South Wales, Australia
  15. 15 Department of Obstetrics and Gynaecology, University of New South Wales, Sydney, New South Wales, Australia
  16. 16 Department of Obstetrics and Gynaecology, Royal Hospital for Women, Randwick, New South Wales, Australia
  17. 17 School of Women's and Children's Health, University of New South Wales, Sydney, New South Wales, Australia
  18. 18 NHMRC Clinical Trials Centre, Camperdown, New South Wales, Australia
  19. 19 Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia
  20. 20 Institute for Health Research, University of Notre Dame Australia, Fremantle, Western Australia, Australia
  21. 21 Institute for Health Research, University of Notre Dame Australia, Fremantle, Western Australia, Australia
  22. 22 Institute for Health Research, University of Notre Dame Australia, Fremantle, Western Australia, Australia
  23. 23 Anatomical Pathology Department, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
  24. 24 School of Medicine, Western Sydney University, Sydney,, New South Wales, Australia
  25. 25 Department of Gynaecological Oncologist, King Edward Memorial Hospital for Women, Subiaco, Western Australia, Australia
  26. 26 Division of Women’s and Infants’ Health, School of Medicine, University of Western Australia, Crawley, Western Australia, Australia
  27. 27 Western Australia Gynaecologic Cancer Service, Perth, Western Australia, Australia
  28. 28 Department of Surgical Education, King Edward Memorial Hospital for Women, Subiaco, Western Australia, Australia
  29. 29 Department of Obstetrics and Gynaecology, King Edward Memorial Hospital for Women, Subiaco, Western Australia, Australia
  30. 30 Consumer and Community Committee, Australia and New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia
  1. Correspondence to Dr Paul A Cohen; paul.cohen{at}sjog.org.au

Abstract

Introduction Adenocarcinoma in situ (AIS) of the uterine cervix is the precursor to invasive endocervical adenocarcinoma. An excisional biopsy such as a cold knife cone biopsy (CKC) should be performed to exclude invasive adenocarcinoma. Loop electrosurgical excision procedure (LEEP) is an alternative modality to CKC but is controversial in AIS. There is a perception that there is a greater likelihood of incomplete excision of AIS with LEEP because the depth of excised tissue tends to be smaller and the tissue margins may show thermal artefact which can interfere with pathology assessment. In the USA, guidelines recommend that any treatment modality can be used to excise AIS, provided that the specimen remains intact with interpretable margins. However, there are no high-quality studies comparing LEEP with CKC and well-designed prospective studies are needed. If such a study were to show that LEEP was non-inferior to CKC for the outcomes of post-treatment persistence, recurrence and adenocarcinoma, LEEP could be recommended as an appropriate treatment option for AIS in selected patients. This would benefit women because, unlike CKC, LEEP does not require general anaesthesia and may be associated with reduced morbidity.

Methods and analysis The proposed exploratory study is a parallel group trial with an allocation ratio of 2:1 in favour of the intervention (LEEP: CKC). Participants are women aged ≥18 to ≤45 years diagnosed with AIS on cervical screening and/or colposcopically directed biopsy in Australia and New Zealand, who are to receive excisional treatment in a tertiary level centre.

Ethics and dissemination Ethical approval for the study has been granted by the St John of God Healthcare Human Research Ethics Committee (reference number #1137). Results from the study will be presented at conferences and published in a peer-reviewed scientific journal.

Registration ANZCTR registration number ACTRN12617000132347 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372173&isReview=true

  • cervical adenocarcinoma in situ
  • cold knife cone biopsy
  • loop electrosurgical excision procedure
  • cervical adenocarcinoma In situ recurrence
  • treatment-related morbidity

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-017576

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    Footnotes

    • Contributors PAC is the principal investigator, conceived the study and wrote the protocol. AB, PS, DCHW, OM, LE, AR, MC, MS, AM, JC, LA, YL, LF and PS assisted in the design of the study and drafting of the protocol. MKB participated in the statistical design of the study and helped draft the protocol. All authors read and approved the final manuscript.

    • Funding This work has been supported by the Australia and New Zealand Gynaecological Oncology Group (ANZGOG) Fund for New Research grant number FNR 2016/03’.

    • Competing interests None declared.

    • Ethics approval St John of God Healthcare Human Research Ethics Committee, Subiaco, Perth, Western Australia 6008, Australia.

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