Abstract：
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.
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.
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).
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.).
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.
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).
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.).
摘要：
目的：不切除的内镜下带状结扎（EBL）联合单切口针刀（SINK）活检可能对小胃肠道上皮下肿瘤（SET）的治疗产生积极影响，但它需要测试。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性队列研究纳入了2017年3月至2020年3月之间CT≤15mm（经超声内镜（EUS）证实）的患者。主要结果是4周临床成功，定义为EUS对照时SET完全消失。次要结果是长期（1年）临床成功，技术难度等级,临床影响，产量病理学，和安全。
结果：政府，NCT03247231。
结果：对273名患者进行了筛查，和122(62.3%是女性，平均年龄60.9±13.2)纳入SET(平均大小，9mm±2.8；胃位置77%，表层依赖性63%)。主要终点为73.6%(95CI64.8-81.2)。在1年的随访中，成功率为68.4%(95CI59.1-76.8)。97例(79.5%,95CI71.3-86.3）。70％的人已知病理诊断。潜在恶性病变占24.7％。相关不良事件发生率为4.1%（95CI1.3-9.3；均为轻度，n=2出血,n=2腹痛）。在多变量分析中，≤10mmSET组的成功率更高(1年，87%；RR5.07[95CI2.63-9.8]）和临床影响率（92.7%；RR6.15[95CI2.72-13.93]。
结论：EBL加SINK活检似乎是可行的，和安全,它可能在小型CT中提供有利的临床影响。具体而言,SET≤10mm是最好的选择。
方法：这项在7个中心开展的前瞻性多中心观察性队列研究纳入了2017年3月至2020年3月之间CT≤15mm（经超声内镜（EUS）证实）的患者。主要结果是4周临床成功，定义为EUS对照时SET完全消失。次要结果是长期（1年）临床成功，技术难度等级,临床影响，产量病理学，和安全。
结果：政府，NCT03247231。
结果：对273名患者进行了筛查，和122(62.3%是女性，平均年龄60.9±13.2)纳入SET(平均大小，9mm±2.8；胃位置77%，表层依赖性63%)。主要终点为73.6%(95CI64.8-81.2)。在1年的随访中，成功率为68.4%(95CI59.1-76.8)。97例(79.5%,95CI71.3-86.3）。70％的人已知病理诊断。潜在恶性病变占24.7％。相关不良事件发生率为4.1%（95CI1.3-9.3；均为轻度，n=2出血,n=2腹痛）。在多变量分析中，≤10mmSET组的成功率更高(1年，87%；RR5.07[95CI2.63-9.8]）和临床影响率（92.7%；RR6.15[95CI2.72-13.93]。
结论：EBL加SINK活检似乎是可行的，和安全,它可能在小型CT中提供有利的临床影响。具体而言,SET≤10mm是最好的选择。
