International radical trachelectomy assessment: IRTA study.
International radical trachelectomy assessment: IRTA study.
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DOI：
10.1136/ijgc-2019-000273
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发表时间：
2019-03
期刊：
影响因子：
--
通讯作者：
Pareja R
中科院分区：
文献类型：
--
作者：
Salvo G;Ramirez PT;Leitao M;Cibula D;Fotopoulou C;Kucukmetin A;Rendon G;Perrotta M;Ribeiro R;Vieira M;Baiocchi G;Falconer H;Persson J;Wu X;Căpilna ME;Ioanid N;Mosgaard BJ;Berlev I;Kaidarova D;Olawaiye AB;Liu K;Nobre SP;Kocian R;Saso S;Rundle S;Noll F;Tsunoda AT;Palsdottir K;Li X;Ulrikh E;Hu Z;Pareja R
根治性气管切除术被认为是低风险早期宫颈癌患者保留生育能力的可行选择。目前的标准方法包括剖腹手术或微创手术进行根治性气管切除术。本研究的目的是比较FIGO (2009) IA2期或IB1期（≤2cm）宫颈癌患者接受开放与微创（腹腔镜或机器人）根治性气管切除术的无病生存率。我们假设微创根治性气管切除术与开放入路相比具有相似的肿瘤预后。这是一项合作的、多机构的、国际性的回顾性研究。在2005年1月1日至2017年12月31日期间接受根治性气管切除术和淋巴结切除术的患者将被纳入研究。需要机构审查委员会的批准。每个机构都可以访问由MD安德森癌症中心维护的研究专用REDCap（研究电子数据采集）数据库，并负责输入患者数据。宫颈癌FIGO (2009) IA2和IB1期（≤2厘米）鳞状、腺癌或腺鳞状将被包括在内。通过开放入路或微创入路（腹腔镜或机器人）进行手术。肿瘤大小>2cm，经体格检查、超声、磁共振、计算机断层扫描或正电子发射断层扫描（至少一次确认肿瘤大小≤2cm）。中心必须提供至少15例根治性气管切除术（开放、微创或两者兼而有之）。既往任何时间宫颈癌骨盆新辅助化疗或放疗，既往淋巴结切除术，或盆腔腹膜后手术，孕妇，流产气管切除术（术中转为根治性子宫切除术），或阴道入路。主要终点是无病生存期（DFS），即从手术到复发或因疾病死亡的时间。为了评估主要目的，我们将比较FIGO (2009) IA2期或IB1期（≤2cm）宫颈癌患者接受开放与微创根治性气管切除术的DFS。估计535例患者将包括：256例开放和279例微创根治性气管切除术。先前的研究表明，开放组的复发率在3.8%至7.6%之间。假设接受开放手术的患者的4.5年无病生存率为95.0%，我们有80%的能力使用α水平0.10检测0.44的风险比。这相当于微创组4.5年无病生存率为89.0%。
Radical trachelectomy is considered a viable option for fertility preservation in patients with low-risk early-stage cervical cancer. Current standard approaches include laparotomy or minimally invasive surgery when performing radical trachelectomy. The aim of this study is to compare disease-free survival between patients with FIGO (2009) stage IA2 or IB1 (≤2cm) cervical cancer who underwent open versus minimally invasive (laparoscopic or robotic) radical trachelectomy. We hypothesize that minimally invasive radical trachelectomy has similar oncologic outcomes compared to the open approach. This is a collaborative, multi-institutional, international, retrospective study. Patients who underwent a radical trachelectomy and lymphadenectomy between January 1, 2005 and December 31, 2017 will be included. Institutional Review Board approval will be required. Each institution will be provided access to a study-specific REDCap (Research Electronic Data Capture) database maintained by MD Anderson Cancer Center and will be responsible for entering patient data. Cervical cancer FIGO (2009) stages IA2 and IB1 (≤2 cm) squamous, adenocarcinoma, or adenosquamous will be included. Surgery performed by the open approach or minimally invasive approach (laparoscopy or robotics). Tumor size >2cm, by physical examination, ultrasound, magnetic resonance imaging, computed tomography, or positron emission tomography (at least one should confirm a tumor size ≤2cm). Centers must contribute at least with 15 cases of radical trachelectomy (open, minimally invasive or both). Prior neoadjuvant chemotherapy or radiotherapy to the pelvis for cervical cancer at any time, prior lymphadenectomy, or pelvic retroperitoneal surgery, pregnant patients, aborted trachelectomy (intra operative conversion to radical hysterectomy), or vaginal approach. The primary endpoint is disease free survival (DFS) measured as the time from surgery until recurrence or death due to disease. To evaluate the primary objective, we will compare DFS among patients with FIGO (2009) stage IA2 or IB1 (≤2cm) cervical cancer who underwent open versus minimally invasive radical trachelectomy. An estimated 535 patients will be included: 256 open and 279 minimally invasive radical trachelectomy. Previous studies have shown that recurrence rates in the open group range from 3.8 to 7.6%. Assuming that the 4.5-year disease free survival rate for patients who underwent open surgery is 95.0%, we have 80% power to detect a 0.44 hazard ratio using alpha level 0.10. This corresponds to an 89.0% disease free survival rate at 4.5 years in the minimally invasive group.
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影响因子：
4.7
作者：
Hertel, Hermann;Koehler, Christhardt;Schneider, Achim
通讯作者：
Schneider, Achim
DOI：
10.1111/igc.0b013e3181b9549a
发表时间：
2009-11-01
影响因子：
4.8
作者：
Cibula, David;Slama, Jiri;Hill, Martin
通讯作者：
Hill, Martin
DOI：
10.1111/j.1471-0528.2004.00421.x
发表时间：
2005-03-01
影响因子：
5.8
作者：
Ungár, L;Pálfalvi, L;Smith, JR
通讯作者：
Smith, JR
影响因子：
4.7
作者：
Ramirez, Pedro T.;Schmeler, Kathleen M.;Soliman, Pamela T.
通讯作者：
Soliman, Pamela T.
DOI：
10.1016/s0950-3552(05)80392-x
发表时间：
1995-12-01
期刊：
BAILLIERES CLINICAL OBSTETRICS AND GYNAECOLOGY
影响因子：
--
作者：
Dargent, D;Mathevet, P
通讯作者：
Mathevet, P