A Randomized Trial of Endoscopic Submucosal Dissection vs Transanal Minimally Invasive Surgery in Early Rectal Neoplasms: DSETAMIS-2018 Study.

Methods

A multicenter, randomized, open-label, noninferiority trial was conducted in 3 Spanish tertiary centers.

在3个西班牙三级中心进行了一项多中心、随机、开放标签、非劣效性试验。

Patients with nonpedunculated ERNs >20 mm and ≤cT1N0 were randomized to TAMIS or ESD.

非带蒂早期直肠癌（ERNs）>20 mm且≤cT1N0的患者被随机分配至经肛门内镜显微手术（TAMIS）或内镜黏膜下剥离术（ESD）治疗。

The primary outcome was 12-month recurrence (noninferiority margin, 10%).

主要结果是12个月内的复发率（非劣效性边界，10%）。

Secondary outcomes included technical success, en bloc, R0, and curative resection rates, procedure time, hospital stay, complications, and costs.

次要结果包括技术成功、整块切除、R0切除和根治性切除率、手术时间、住院时间、并发症和成本。

Analyses followed intention-to-treatand per-protocol (PP) principles.

分析遵循意向治疗和按方案（PP）原则。

Results

Of 185 evaluated patients, 73 were randomized (34 TAMIS, 39 ESD) and 66 (90.4%) completed follow-up.

在评估的185名患者中，有73名被随机分配（34名TAMIS，39名ESD），并且有66名（90.4%）完成了随访。

Local recurrence occurred in 2 TAMIS patients and none in ESD.

局部复发发生在2名TAMIS患者中，而ESD中无一例发生。

The 12-month recurrence risk difference was -6.7% (90% confidence interval, -14.2 to 0.8) in intention-to-treatand -8.3% (90% confidence interval, -17.6 to 0.9) in PP analysis.

意向治疗分析中，12个月复发风险差异为-6.7%（90%置信区间，-14.2至0.8），而在PP分析中为-8.3%（90%置信区间，-17.6至0.9）。

ESD demonstrated shorter hospital stays (1 vs 2 days) and higher technical success (100% vs 88.9%; PP).

内镜下黏膜剥离术（ESD）显示出更短的住院时间（1天对比2天）和更高的技术成功率（100%对比88.9%；PP分析）。

No significant differences were observed in overall complications.

总体并发症方面未观察到显著差异。

Estimated overall costs were €11,289.27 for TAMIS vs €6167.14 for ESD.

TAMIS的估计总成本为11,289.27欧元，而ESD为6167.14欧元。

Of the 112 off-study cases, 108 (96.4%) were successfully treated with ESD.

在112例退出研究的病例中，有108例（96.4%）成功接受了内镜黏膜下剥离术（ESD）治疗。

Conclusions

ESD appears to be noninferior to TAMIS for local resection of ERNs regarding 12-month recurrence.

在局部切除早期胃肠道间质瘤（ERNs）的12个月复发率方面，内镜黏膜下剥离术（ESD）似乎不劣于经肛门微创手术（TAMIS）。

Both show favorable safety profiles.

两者均显示出良好的安全性。

ESD was associated with fewer technical constraints, higher procedural success, shorter hospitalization, lower cost, and greater patient acceptance.

内镜下黏膜剥离术（ESD）与较少的技术限制、更高的手术成功率、更短的住院时间、更低的成本以及更高的患者接受度相关。

These results should be interpreted considering the wide noninferiority margin, limited sample size, and absence of multiplicity adjustment.

在解释这些结果时，应考虑非劣效性边界较宽、样本量有限以及缺乏多重性调整。

(ClinicalTrials.gov, Number: NCT03959839).

(ClinicalTrials.gov, 编号: NCT03959839).