Aizawa Masato, Utano Kenichi, Tsunoda Takuya, Ichii Osamu, Kato Takashi, Miyakura Yasuyuki, Saka Mitsuru, Nemoto Daiki, Isohata Noriyuki, Endo Shungo, Ejiri Yutaka, Lefor Alan Kawarai, Togashi Kazutomo
Department of Coloproctology, Aizu Medical Center Fukushima Medical University, Fukushima, Japan.
Department of Gastroenterology, Takeda General Hospital, Fukushima, Japan.
Endosc Int Open. 2019 Sep;7(9):E1123-E1129. doi: 10.1055/a-0854-3561. Epub 2019 Aug 29.
Delayed bleeding is believed to occur less frequently after cold snare polypectomy (CSP), but this has not been validated in clinical trials. This study aimed to compare rates of delayed bleeding after CSP and hot snare polypectomy (HSP). We conducted a multicenter, randomized controlled trial. Participants scheduled to undergo endoscopic resection of colorectal polyps ≤ 10 mm were enrolled and randomly assigned to CSP or HSP. Prophylactic clipping was performed at the endoscopists' discretion. The primary outcome was delayed bleeding rate. Secondary outcomes included immediate bleeding rate and clipping rate. Sample size calculation showed that 451 patients were required in each arm. At the end of the study period decided in advance, 308 participants were recruited and an interim analysis was performed. A total of 273 patients (mean age 62.2 ± 8.8 years; 188 males) were analyzed, with 139 patients allocated to CSP and 134 to HSP. In total, 367 polyps were resected with CSP and 360 polyps with HSP. There were no significant differences in patient demographics or polyp characteristics. In per-patient-based analysis, delayed bleeding rates were 0.7 % after CSP and 0.7 % after HSP. Per-polyp analysis showed similar results (CSP: 0.3 % vs. HSP: 0.6 %). The immediate bleeding rate was significantly higher with CSP vs. HSP (54 % vs.14 %, < 0.0001), while clipping rates were 18 % and 19 %, respectively. This interim analysis did not demonstrate that delayed bleeding after CSP is less frequent than after HSP. The delayed bleeding rate after HSP was lower than expected. Meeting presentations: Digestive Disease Week 2017.
人们认为冷圈套息肉切除术（CSP）后迟发性出血的发生率较低，但这尚未在临床试验中得到验证。本研究旨在比较CSP和热圈套息肉切除术（HSP）后迟发性出血的发生率。 我们进行了一项多中心随机对照试验。计划接受内镜切除≤10毫米大肠息肉的参与者被纳入研究，并随机分配接受CSP或HSP。预防性夹闭由内镜医师自行决定。主要结局是迟发性出血率。次要结局包括即时出血率和夹闭率。样本量计算表明每组需要451例患者。 在预先确定的研究期结束时，招募了308名参与者并进行了中期分析。共分析了273例患者（平均年龄62.2±8.8岁；男性188例），其中139例患者分配接受CSP，134例接受HSP。总共用CSP切除了367个息肉，用HSP切除了360个息肉。患者人口统计学或息肉特征无显著差异。在基于患者的分析中，CSP后迟发性出血率为0.7%，HSP后为0.7%。基于息肉的分析显示了类似结果（CSP：0.3%对HSP：0.6%）。CSP的即时出血率显著高于HSP（54%对14%，<0.0001），而夹闭率分别为18%和19%。 这项中期分析并未表明CSP后迟发性出血的发生率低于HSP后。HSP后的迟发性出血率低于预期。会议报告：2017年消化系统疾病周。
