Objective Endoscopic full-thickness resection (EFTR) is a novel treatment of colorectal lesions not amenable to conventional endoscopic resection. The aim of this prospective multicentre study was to assess the efficacy and safety of the full-thickness resection device. Design 181 patients were recruited in 9 centres with the indication of difficult adenomas (non-lifting and/or at difficult locations), early cancers and subepithelial tumours (SET). Primary endpoint was complete en bloc and R0 resection. Results EFTR was technically successful in 89.5%, R0 resection rate was 76.9%. In 127 patients with difficult adenomas and benign histology, R0 resection rate was 77.7%. In 14 cases, lesions harboured unsuspected cancer, another 15 lesions were primarily known as cancers. Of these 29 cases, R0 resection was achieved in 72.4%; 8 further cases had deep submucosal infiltration >1000 µm. Therefore, curative resection could only be achieved in 13/29 (44.8%). In the subgroup with SET (n=23), R0 resection rate was 87.0%. In general, R0 resection rate was higher with lesions ≤2 cm vs >2 cm (81.2% vs 58.1%, p=0.0038). Adverse event rate was 9.9% with a 2.2% rate of emergency surgery. Three-month follow-up was available from 154 cases and recurrent/residual tumour was evident in 15.3%. Conclusion EFTR has a reasonable technical efficacy especially in lesions ≤2 cm with acceptable complication rates. Curative resection rate for early cancers was too low to recommend its primary use in this indication. Further comparative studies have to show the clinical value and long-term outcome of EFTR in benign colorectal lesions. Trial registration number NCT02362126; Results.

中文翻译：

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使用超范围装置进行结肠镜全层切除：一项针对各种适应症的前瞻性多中心研究

目的内镜全层切除术（EFTR）是一种新的治疗结直肠病变的方法，不适合常规内镜切除术。这项前瞻性多中心研究的目的是评估全层切除装置的有效性和安全性。设计 在 9 个中心招募了 181 名具有困难腺瘤（非提升和/或困难位置）、早期癌症和上皮下肿瘤 (SET) 适应症的患者。主要终点是完全整块和 R0 切除。结果EFTR技术成功率为89.5%，R0切除率为76.9%。127例难治性腺瘤组织学良性患者，R0切除率为77.7%。在 14 个病例中，病变包含未预料到的癌症，另外 15 个病变主要被称为癌症。在这 29 例中，72.4% 的患者实现了 R0 切除；另外 8 例有深度黏膜下浸润 >1000 µm。因此，只能在 13/29 (44.8%) 中实现根治性切除。在 SET 亚组 (n=23) 中，R0 切除率为 87.0%。一般而言，病灶≤2 cm 与>2 cm 的R0 切除率更高（81.2% 与58.1%，p=0.0038）。不良事件发生率为 9.9%，急诊手术率为 2.2%。154 例患者进行了 3 个月的随访，15.3% 的患者有明显的复发/残留肿瘤。结论 EFTR具有合理的技术疗效，尤其是对≤2 cm的病灶，并发症发生率可接受。早期癌症的治愈性切除率太低，无法推荐其主要用于该适应症。进一步的比较研究必须显示 EFTR 在良性结直肠病变中的临床价值和长期结果。试验注册号NCT02362126；结果。