Division of Digestive Endoscopy and Gastroenterology, Valduce Hospital, Como, Italy.
Department of Gastroenterology, Nuovo Regina Margherita Hospital, Roma, Italy.
United European Gastroenterol J. 2019 Dec;7(10):1361-1372. doi: 10.1177/2050640619874176. Epub 2019 Sep 23.
The safety of endoscopic resection of large colorectal lesions (LCLs) (≥20 mm) is clinically relevant. The aim of the present study was to assess the rate of post-resection adverse events (AEs) in a real-life setting.
In a prospective, multicentre, observational study, data from consecutive resections of LCLs over a 6-month period were collected in 24 centres. Patients were followed up at 15 days from resection for AEs. The primary endpoint was intra-procedural bleeding according to lesion morphology. Secondary endpoints were delayed bleeding and perforation. Patient and polyp characteristics, and polypectomy techniques were analysed with respect to the bleeding events.
In total, 1504 patients (female/male: 633/871, mean age, 66.1) with 1648 LCLs (29.1% pedunculated and 70.9% non-pedunculated lesions) were included. Overall, 168 (11.2%) patients had post-resection bleeding (8.5 and 2.0% immediate and delayed, respectively), while 15 (1.0%) cases of perforation occurred. Independent predictors of immediate bleeding for pedunculated lesions were bleeding prophylaxis (odds ratio (OR) 0.28, 95% confidence interval (CI) 0.13-0.62), simple polypectomy (versus endoscopic mucosal resection, OR 0.38, 95% CI 0.17-0.88) and inpatient setting (OR 2.21, 95% CI 1.07-5.08), while bleeding prophylaxis (OR 0.37, 95% CI 0.30-0.98), academic setting (OR 0.27, 95% CI 0.12-0.54) and size (OR 1.03, 95% CI 1.00-1.05) were predictors for those non-pedunculated. Indication for colonoscopy (screening versus diagnostic (OR 0.33, 95% CI 0.12-0.86)), antithrombotic therapy (OR 3.12, 95% CI 1.54-6.39) and size (OR 2.34, 95% CI 1.12-4.87) independently predicted delayed bleeding.
A low rate of post-resection AEs was observed in a real-life setting, reassuring as to the safety of endoscopic resection of ≥2 cm colorectal lesions. Bleeding prophylaxis reduced the intra-procedural bleeding risk, while antithrombotic therapy increased delayed bleeding.CLINICALTRIAL: (NCT02694120).
内镜切除大肠大病变(LCL)(≥20mm)的安全性具有临床意义。本研究旨在评估真实环境下内镜切除术后不良事件(AE)的发生率。
在一项前瞻性、多中心、观察性研究中,24 个中心在 6 个月内连续收集 LCL 切除术的数据。患者在切除后 15 天进行 AE 随访。主要终点为根据病变形态评估术中出血。次要终点为迟发性出血和穿孔。分析患者和息肉特征以及息肉切除术技术与出血事件的关系。
共纳入 1504 例患者(女性/男性:633/871,平均年龄 66.1 岁),1648 个 LCL(29.1%为有蒂,70.9%为无蒂病变)。总体而言,168 例(11.2%)患者术后发生出血(8.5%和 2.0%为即时和迟发性出血),15 例(1.0%)发生穿孔。有蒂病变即刻出血的独立预测因素为出血预防(比值比(OR)0.28,95%置信区间(CI)0.13-0.62)、单纯息肉切除术(内镜黏膜切除术,OR 0.38,95%CI 0.17-0.88)和住院治疗(OR 2.21,95%CI 1.07-5.08),而出血预防(OR 0.37,95%CI 0.30-0.98)、学术环境(OR 0.27,95%CI 0.12-0.54)和大小(OR 1.03,95%CI 1.00-1.05)是无蒂病变的预测因素。结肠镜检查指征(筛查与诊断(OR 0.33,95%CI 0.12-0.86))、抗血栓治疗(OR 3.12,95%CI 1.54-6.39)和大小(OR 2.34,95%CI 1.12-4.87)独立预测迟发性出血。
在真实环境中观察到内镜切除术后不良事件发生率较低,这对于≥2cm 大肠病变的内镜切除安全性是令人安心的。出血预防降低了术中出血风险,而抗血栓治疗增加了迟发性出血的风险。
(NCT02694120)。