Department of Gastroenterology & Hepatology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
Department of Gastroenterology & Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands.
BMC Gastroenterol. 2020 Jul 13;20(1):225. doi: 10.1186/s12876-020-01367-z.
In the recent years two innovative approaches have become available for minimally invasive en bloc resections of large non-pedunculated rectal lesions (polyps and early cancers). One is Transanal Minimally Invasive Surgery (TAMIS), the other is Endoscopic Submucosal Dissection (ESD). Both techniques are standard of care, but a direct randomised comparison is lacking. The choice between either of these procedures is dependent on local expertise or availability rather than evidence-based. The European Society for Endoscopy has recommended that a comparison between ESD and local surgical resection is needed to guide decision making for the optimal approach for the removal of large rectal lesions in Western countries. The aim of this study is to directly compare both procedures in a randomised setting with regard to effectiveness, safety and perceived patient burden.
Multicenter randomised trial in 15 hospitals in the Netherlands. Patients with non-pedunculated lesions > 2 cm, where the bulk of the lesion is below 15 cm from the anal verge, will be randomised between either a TAMIS or an ESD procedure. Lesions judged to be deeply invasive by an expert panel will be excluded. The primary endpoint is the cumulative local recurrence rate at follow-up rectoscopy at 12 months. Secondary endpoints are: 1) Radical (R0-) resection rate; 2) Perceived burden and quality of life; 3) Cost effectiveness at 12 months; 4) Surgical referral rate at 12 months; 5) Complication rate; 6) Local recurrence rate at 6 months. For this non-inferiority trial, the total sample size of 198 is based on an expected local recurrence rate of 3% in the ESD group, 6% in the TAMIS group and considering a difference of less than 6% to be non-inferior.
This is the first European randomised controlled trial comparing the effectiveness and safety of TAMIS and ESD for the en bloc resection of large non-pedunculated rectal lesions. This is important as the detection rate of these adenomas is expected to further increase with the introduction of colorectal screening programs throughout Europe. This study will therefore support an optimal use of healthcare resources in the future.
Netherlands Trial Register, NL7083 , 06 July 2018.
近年来，对于非息肉状的大型直肠病变（息肉和早期癌症）的微创整块切除术，出现了两种创新方法。一种是经肛门微创外科手术（TAMIS），另一种是内镜黏膜下剥离术（ESD）。这两种技术都是标准的治疗方法，但缺乏直接的随机比较。选择这两种方法中的任何一种都取决于当地的专业知识或可用性，而不是基于证据的方法。欧洲内镜学会建议，需要对 ESD 和局部手术切除进行比较，以指导西方国家治疗大型直肠病变的最佳方法的决策。本研究的目的是在随机环境中直接比较这两种方法，以评估其有效性、安全性和患者的感知负担。
荷兰 15 家医院的多中心随机试验。将直径>2cm 的非息肉状病变，且病变大部分位于肛缘以下 15cm 以内的患者随机分为 TAMIS 或 ESD 组。由专家小组判断为深部浸润性病变的患者将被排除在外。主要终点是 12 个月时直肠镜复查时的累积局部复发率。次要终点是：1）根治性（R0-）切除率；2）患者的感知负担和生活质量；3）12 个月时的成本效益；4）12 个月时的手术转诊率；5）并发症发生率；6）6 个月时的局部复发率。对于这项非劣效性试验，根据 ESD 组 3%、TAMIS 组 6%的预计局部复发率和考虑差异小于 6%为非劣效性，确定了 198 例的总样本量。
这是第一项比较 TAMIS 和 ESD 整块切除大型非息肉状直肠病变的有效性和安全性的欧洲随机对照试验。这一点很重要，因为随着欧洲各地结直肠癌筛查计划的引入，这些腺瘤的检出率预计会进一步增加。因此，这项研究将支持未来对医疗保健资源的最佳利用。
荷兰试验注册中心，NL7083，2018 年 7 月 6 日。
