Background and Aims

Endoscopic band ligation (EBL) without resection combined with single-incision needle-knife (SINK) biopsy sampling may have a positive impact on small GI subepithelial tumor (SET) management, but the method needs to be tested. The aim was to evaluate the feasibility of this strategy in small-sized SETs.

Methods

This prospective multicenter observational cohort study in 7 centers included patients with SETs ≤15 mm (confirmed by EUS) between March 2017 and March 2020. The primary outcome was clinical success at 4 weeks, defined as complete SET disappearance on EUS. Secondary outcomes were long-term (1-year) clinical success, technical difficulty level, clinical impact, yield pathology, and safety.

Results

Of 273 patients screened, 122 (62.3% women; mean age, 60.9 ± 13.2 years) were included with SETs (mean size, 9 ± 2.8 mm; gastric location, 77%; superficial layer dependence, 63%). The primary endpoint was achieved in 73.6% of patients (95% confidence interval [CI], 64.8-81.2). At the 1-year follow-up, the success rate was 68.4% (95% CI, 59.1-76.8). A favorable clinical impact was observed in 97 cases (79.5%; 95% CI, 71.3-86.3). Pathology diagnosis was known in 70%. Potentially malignant lesions were present in 24.7%. The related adverse events rate was 4.1% (95% CI, 1.3-9.3; all mild: 2 bleeding, 2 abdominal pain). On multivariable analysis, the ≤10-mm SET group was associated with a greater success rate (1 year, 87%; relative risk, 5.07; 95% CI, 2.63-9.8) and clinical impact rate (92.7%; relative risk, 6.15; 95% CI, 2.72-13.93).

Conclusions

EBL plus SINK biopsy sampling seems to be feasible and safe, and it may offer a favorable clinical impact in small-sized SETs. In particular, SETs ≤10 mm are the best candidates. (Clinical trial registration number: NCT03247231.)

中文翻译：

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通过内窥镜束带不切除和单切口针刀辅助活检取样治疗小型上皮下肿瘤：一项前瞻性多中心研究

背景和目标

不切除的内镜带状结扎术（EBL）联合单切口针刀（SINK）活检取样可能对小胃肠道上皮下肿瘤（SET）的治疗产生积极影响，但该方法需要进行测试。目的是评估该策略在小型 SET 中的可行性。

方法

这项在 7 个中心开展的前瞻性多中心观察队列研究纳入了 2017 年 3 月至 2020 年 3 月期间 SET ≤ 15 mm（经 EUS 确认）的患者。主要结局是 4 周时的临床成功，定义为 EUS 上 SET 完全消失。次要结局是长期（1 年）临床成功、技术难度水平、临床影响、产量病理学和安全性。

结果

在筛选的 273 名患者中，122 名（62.3% 为女性；平均年龄，60.9 ± 13.2 岁）纳入 SET（平均大小，9 ± 2.8 毫米；胃位置，77%；浅层依赖性，63%）。73.6% 的患者实现了主要终点（95% 置信区间 [CI]，64.8-81.2）。1 年随访时，成功率为 68.4%（95% CI，59.1-76.8）。在 97 例病例中观察到良好的临床效果（79.5%；95% CI，71.3-86.3）。病理诊断已知率为70%。24.7% 存在潜在恶性病变。相关不良事件发生率为 4.1%（95% CI，1.3-9.3；全部为轻度：2 例出血、2 例腹痛）。在多变量分析中，≤10 mm SET 组与较高的成功率（1 年，87%；相对风险，5.07；95% CI，2.63-9.8）和临床影响率（92.7%；相对风险，6.15）相关。 ；95% CI，2.72-13.93）。

结论

EBL 加 SINK 活检取样似乎可行且安全，并且可能在小型 SET 中提供有利的临床影响。特别是，SET ≤10 mm 是最佳候选。（临床试验注册号：NCT03247231。）