腹腔镜或机器人根治性手术中使用内镜吻合器抑制宫颈恶性肿瘤肿瘤播散的安全性和有效性研究（SOLUTION）：一项多中心、开放标签、单臂、Ⅱ期试验方案。
Safety and efficacy study of laparoscopic or robotic radical surgery using an endoscopic stapler for inhibiting tumour spillage of cervical malignant neoplasms evaluating survival (SOLUTION): a multi-centre, open-label, single-arm, phase II trial protocol.
机构信息
Department of Obstetrics and Gynecology, Seoul National University College of Medicine, 101 Daehak-Ro Jongno-Gu, Seoul, 03080, Republic of Korea.
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine, Suwon, 16499, South Korea.
出版信息
BMC Cancer. 2022 Mar 26;22(1):331. doi: 10.1186/s12885-022-09429-z.
BACKGROUND
The Laparoscopic Approach to Cervical Cancer trial and Surveillance, Epidemiology, and End Results program database study demonstrated that minimally invasive radical hysterectomy was inferior to abdominal radical hysterectomy in terms of disease recurrence and survival. Among risk factors related to poor prognosis after minimally invasive surgery (MIS), tumour spillage during intracorporeal colpotomy became a significant issue. Thus, we designed this trial to evaluate the efficacy and safety of minimally invasive radical hysterectomy using an endoscopic stapler for early-stage cervical cancer.
METHODS
This trial is a prospective, multi-centre, open-label, single-arm, non-inferiority phase II study. The nine organisations will participate in this trial after the approval of the institutional review board. Major eligibility criteria include women aged 20 years or older with cervical cancer stage IB1 squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma according to the revised 2009 FIGO staging system who will undergo type B2 or C hysterectomy by MIS. The primary endpoint is the 4.5-year disease-free survival (DFS) rate between abdominal radical hysterectomy and MIS using an endoscopic stapler. For calculating the sample size, we hypothesised that the 4.5-year DFS rate after MIS using an endoscopic stapler is assumed to be the same after abdominal radical hysterectomy at 90.9%, and the non-inferiority margin was 7.2%. When we consider a three-year accrual and 4.5-year follow-up, at least 13 events must happen, requiring a total of 111 patients assuming a statistical power of 80% and the one-tailed test of 5% significance. A total of 124 patients is needed, considering a drop-out rate of 10%.
DISCUSSION
We expect intracorporeal colpotomy using an endoscopic stapler may prevent tumour spillage during MIS for stage IB1 cervical cancer, showing a comparable prognosis with abdominal radical surgery.
TRIAL REGISTRATION
ClinicalTrials.gov ; NCT04370496 ; registration date, May 2020.
背景
腹腔镜宫颈癌治疗和监测、流行病学和最终结果（SEER）数据库研究表明，微创根治性子宫切除术在疾病复发和生存方面不如腹式根治性子宫切除术。在与微创手术（MIS）后预后不良相关的危险因素中，体腔切开时肿瘤溢出成为一个重要问题。因此，我们设计了这项试验，以评估使用内镜吻合器治疗早期宫颈癌的微创根治性子宫切除术的疗效和安全性。
方法
这是一项前瞻性、多中心、开放性、单臂、非劣效性 II 期研究。在机构审查委员会批准后，九个机构将参与这项试验。主要入选标准包括年龄在 20 岁及以上、FIGO 修订 2009 分期系统为 IB1 期的宫颈癌鳞癌、腺癌或腺鳞癌患者，接受经 MIS 行 B2 或 C 型子宫切除术。主要终点是腹式根治性子宫切除术与 MIS 用内镜吻合器治疗的 4.5 年无病生存率（DFS）。在计算样本量时，我们假设 MIS 用内镜吻合器治疗的 4.5 年 DFS 率与腹式根治性子宫切除术相同，为 90.9%，非劣效性边界为 7.2%。考虑到 3 年入组和 4.5 年随访，至少需要发生 13 个事件，需要总共 111 例患者，假设统计效力为 80%，单侧检验显著性为 5%。考虑到 10%的脱落率，需要 124 例患者。
讨论
我们预计使用内镜吻合器的体腔切开术可防止 IB1 期宫颈癌 MIS 时肿瘤溢出，显示出与腹式根治手术相当的预后。
试验注册
ClinicalTrials.gov；NCT04370496；注册日期，2020 年 5 月。
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