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

Paul A. Cohen, Alison Brand, Peter Sykes, David C.H. Wrede, Orla McNally, Lois Eva, Archana Rao, Michael Campion, Martin Stockler, Aime Powell, Jim Codde, Max Bulsara, Lyndal Anderson, Yee Leung, Louise Farrell, Pennie Stoyles

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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.
Original languageEnglish
Article numbere017576
JournalBMJ Open
Volume7
Issue number8
DOIs
Publication statusPublished - Aug 2017

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Biopsy
Recurrence
Adenocarcinoma
Therapeutics
Adenocarcinoma in Situ
Non-Randomized Controlled Trials
New Zealand
Cervix Uteri
Artifacts
General Anesthesia
Hot Temperature
Prospective Studies
Guidelines
Pathology
Morbidity

Cite this

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 ; 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. In: BMJ Open. 2017 ; Vol. 7, No. 8.
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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.",
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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; Anderson, Lyndal; Leung, Yee; Farrell, Louise ; Stoyles, Pennie .

In: BMJ Open, Vol. 7, No. 8, e017576, 08.2017.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 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

AU - Cohen, Paul A.

AU - Brand, Alison

AU - Sykes, Peter

AU - Wrede, David C.H.

AU - McNally, Orla

AU - Eva, Lois

AU - Rao, Archana

AU - Campion, Michael

AU - Stockler, Martin

AU - Powell, Aime

AU - Codde, Jim

AU - Bulsara, Max

AU - Anderson, Lyndal

AU - Leung, Yee

AU - Farrell, Louise

AU - Stoyles, Pennie

PY - 2017/8

Y1 - 2017/8

N2 - 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.

AB - 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.

U2 - 10.1136/bmjopen-2017-017576

DO - 10.1136/bmjopen-2017-017576

M3 - Article

VL - 7

JO - BMJ (Open)

JF - BMJ (Open)

SN - 2044-6055

IS - 8

M1 - e017576

ER -