Cargando…

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

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 alternat...

Descripción completa

Detalles Bibliográficos
Autores principales: Cohen, Paul A, Brand, Alison, Sykes, Peter, Wrede, David C H, McNally, Orla, Eva, Lois, Rao, Archana, Campion, Michael, Stockler, Martin, Powell, Aime, Codde, Jim, Bulsara, Max K, Anderson, Lyndal, Leung, Yee, Farrell, Louise, Stoyles, Pennie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5724204/
https://www.ncbi.nlm.nih.gov/pubmed/28851799
http://dx.doi.org/10.1136/bmjopen-2017-017576
_version_ 1783285319577108480
author Cohen, Paul A
Brand, Alison
Sykes, Peter
Wrede, David C H
McNally, Orla
Eva, Lois
Rao, Archana
Campion, Michael
Stockler, Martin
Powell, Aime
Codde, Jim
Bulsara, Max K
Anderson, Lyndal
Leung, Yee
Farrell, Louise
Stoyles, Pennie
author_facet Cohen, Paul A
Brand, Alison
Sykes, Peter
Wrede, David C H
McNally, Orla
Eva, Lois
Rao, Archana
Campion, Michael
Stockler, Martin
Powell, Aime
Codde, Jim
Bulsara, Max K
Anderson, Lyndal
Leung, Yee
Farrell, Louise
Stoyles, Pennie
author_sort Cohen, Paul A
collection PubMed
description 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
format Online
Article
Text
id pubmed-5724204
institution National Center for Biotechnology Information
language English
publishDate 2017
publisher BMJ Publishing Group
record_format MEDLINE/PubMed
spelling pubmed-57242042017-12-19 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 Cohen, Paul A Brand, Alison Sykes, Peter Wrede, David C H McNally, Orla Eva, Lois Rao, Archana Campion, Michael Stockler, Martin Powell, Aime Codde, Jim Bulsara, Max K Anderson, Lyndal Leung, Yee Farrell, Louise Stoyles, Pennie BMJ Open Obstetrics and Gynaecology 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 BMJ Publishing Group 2017-08-28 /pmc/articles/PMC5724204/ /pubmed/28851799 http://dx.doi.org/10.1136/bmjopen-2017-017576 Text en © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. 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/
spellingShingle Obstetrics and Gynaecology
Cohen, Paul A
Brand, Alison
Sykes, Peter
Wrede, David C H
McNally, Orla
Eva, Lois
Rao, Archana
Campion, Michael
Stockler, Martin
Powell, Aime
Codde, Jim
Bulsara, Max K
Anderson, Lyndal
Leung, Yee
Farrell, Louise
Stoyles, Pennie
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Obstetrics and Gynaecology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5724204/
https://www.ncbi.nlm.nih.gov/pubmed/28851799
http://dx.doi.org/10.1136/bmjopen-2017-017576
work_keys_str_mv AT cohenpaula excisionaltreatmentinwomenwithcervicaladenocarcinomainsituaisaprospectiverandomisedcontrollednoninferioritytrialtocompareaispersistencerecurrenceafterloopelectrosurgicalexcisionprocedurewithcoldknifeconebiopsyprotocolforapilotstudy
AT brandalison excisionaltreatmentinwomenwithcervicaladenocarcinomainsituaisaprospectiverandomisedcontrollednoninferioritytrialtocompareaispersistencerecurrenceafterloopelectrosurgicalexcisionprocedurewithcoldknifeconebiopsyprotocolforapilotstudy
AT sykespeter excisionaltreatmentinwomenwithcervicaladenocarcinomainsituaisaprospectiverandomisedcontrollednoninferioritytrialtocompareaispersistencerecurrenceafterloopelectrosurgicalexcisionprocedurewithcoldknifeconebiopsyprotocolforapilotstudy
AT wrededavidch excisionaltreatmentinwomenwithcervicaladenocarcinomainsituaisaprospectiverandomisedcontrollednoninferioritytrialtocompareaispersistencerecurrenceafterloopelectrosurgicalexcisionprocedurewithcoldknifeconebiopsyprotocolforapilotstudy
AT mcnallyorla excisionaltreatmentinwomenwithcervicaladenocarcinomainsituaisaprospectiverandomisedcontrollednoninferioritytrialtocompareaispersistencerecurrenceafterloopelectrosurgicalexcisionprocedurewithcoldknifeconebiopsyprotocolforapilotstudy
AT evalois excisionaltreatmentinwomenwithcervicaladenocarcinomainsituaisaprospectiverandomisedcontrollednoninferioritytrialtocompareaispersistencerecurrenceafterloopelectrosurgicalexcisionprocedurewithcoldknifeconebiopsyprotocolforapilotstudy
AT raoarchana excisionaltreatmentinwomenwithcervicaladenocarcinomainsituaisaprospectiverandomisedcontrollednoninferioritytrialtocompareaispersistencerecurrenceafterloopelectrosurgicalexcisionprocedurewithcoldknifeconebiopsyprotocolforapilotstudy
AT campionmichael excisionaltreatmentinwomenwithcervicaladenocarcinomainsituaisaprospectiverandomisedcontrollednoninferioritytrialtocompareaispersistencerecurrenceafterloopelectrosurgicalexcisionprocedurewithcoldknifeconebiopsyprotocolforapilotstudy
AT stocklermartin excisionaltreatmentinwomenwithcervicaladenocarcinomainsituaisaprospectiverandomisedcontrollednoninferioritytrialtocompareaispersistencerecurrenceafterloopelectrosurgicalexcisionprocedurewithcoldknifeconebiopsyprotocolforapilotstudy
AT powellaime excisionaltreatmentinwomenwithcervicaladenocarcinomainsituaisaprospectiverandomisedcontrollednoninferioritytrialtocompareaispersistencerecurrenceafterloopelectrosurgicalexcisionprocedurewithcoldknifeconebiopsyprotocolforapilotstudy
AT coddejim excisionaltreatmentinwomenwithcervicaladenocarcinomainsituaisaprospectiverandomisedcontrollednoninferioritytrialtocompareaispersistencerecurrenceafterloopelectrosurgicalexcisionprocedurewithcoldknifeconebiopsyprotocolforapilotstudy
AT bulsaramaxk excisionaltreatmentinwomenwithcervicaladenocarcinomainsituaisaprospectiverandomisedcontrollednoninferioritytrialtocompareaispersistencerecurrenceafterloopelectrosurgicalexcisionprocedurewithcoldknifeconebiopsyprotocolforapilotstudy
AT andersonlyndal excisionaltreatmentinwomenwithcervicaladenocarcinomainsituaisaprospectiverandomisedcontrollednoninferioritytrialtocompareaispersistencerecurrenceafterloopelectrosurgicalexcisionprocedurewithcoldknifeconebiopsyprotocolforapilotstudy
AT leungyee excisionaltreatmentinwomenwithcervicaladenocarcinomainsituaisaprospectiverandomisedcontrollednoninferioritytrialtocompareaispersistencerecurrenceafterloopelectrosurgicalexcisionprocedurewithcoldknifeconebiopsyprotocolforapilotstudy
AT farrelllouise excisionaltreatmentinwomenwithcervicaladenocarcinomainsituaisaprospectiverandomisedcontrollednoninferioritytrialtocompareaispersistencerecurrenceafterloopelectrosurgicalexcisionprocedurewithcoldknifeconebiopsyprotocolforapilotstudy
AT stoylespennie excisionaltreatmentinwomenwithcervicaladenocarcinomainsituaisaprospectiverandomisedcontrollednoninferioritytrialtocompareaispersistencerecurrenceafterloopelectrosurgicalexcisionprocedurewithcoldknifeconebiopsyprotocolforapilotstudy