宫颈原位腺癌（AIS）女性患者的切除治疗：一项前瞻性随机对照非劣效性试验，比较环形电切术与冷刀锥切术后AIS的持续/复发情况：一项试点研究方案
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.
作者信息
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
机构信息
Division of Women's and Infants' Health, School of Medicine, University of Western Australia, Crawley, Western Australia, Australia.
Department of Gynaecological Oncology, King Edward Memorial Hospital for Women, Subiaco, Western Australia, Australia.
出版信息
BMJ Open. 2017 Aug 28;7(8):e017576. doi: 10.1136/bmjopen-2017-017576.
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.
引言
子宫颈原位腺癌（AIS）是浸润性宫颈管腺癌的前驱病变。应进行切除活检，如冷刀锥切活检（CKC），以排除浸润性腺癌。环形电切术（LEEP）是CKC的替代方法，但在AIS中存在争议。有一种观点认为，LEEP切除AIS不完全的可能性更大，因为切除组织的深度往往较小，且组织边缘可能显示热伪像，这会干扰病理评估。在美国，指南建议任何治疗方式均可用于切除AIS，前提是标本保持完整且切缘可解读。然而，尚无比较LEEP与CKC的高质量研究，需要设计良好的前瞻性研究。如果这样一项研究表明，对于治疗后持续存在、复发和腺癌等结局，LEEP不劣于CKC，那么LEEP可被推荐为特定患者AIS的合适治疗选择。这将使女性受益，因为与CKC不同，LEEP不需要全身麻醉，且可能与较低的发病率相关。
方法与分析
拟进行的探索性研究是一项平行组试验，分配比例为2:1，倾向于干预组（LEEP: CKC）。参与者为年龄在18岁及以上至45岁及以下、在澳大利亚和新西兰经宫颈筛查和/或阴道镜引导活检诊断为AIS、并将在三级中心接受切除治疗的女性。
伦理与传播
该研究已获得上帝之约翰医疗保健人类研究伦理委员会的伦理批准（参考编号#1137）。研究结果将在会议上展示，并发表在同行评审的科学期刊上。
注册
澳大利亚和新西兰临床试验注册中心注册号ACTRN12617000132347 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372173&isReview=true
Zotero 插件