Division of Digestive Endoscopy, Shiga University of Medical Science Hospital, Shiga 520-2192, Japan.
Department of Gastroenterology, Shiga University of Medical Science Hospital, Shiga 520-2192, Japan.
World J Gastroenterol. 2018 Sep 21;24(35):4077-4085. doi: 10.3748/wjg.v24.i35.4077.
To prospectively investigate the efficacy and safety of clip-flap assisted endoscopic submucosal dissection (ESD) for gastric tumors.
From May 2015 to October 2016, we enrolled 104 patients with gastric cancer or adenoma scheduled for ESD at Shiga University of Medical Science Hospital. We randomized patients into two subgroups using the minimization method based on location of the tumor (upper, middle or lower third of the stomach), tumor size (< 20 mm or > 20 mm) and ulcer status: ESD using an endoclip (the clip-flap group) and ESD without an endoclip (the conventional group). Therapeutic efficacy (procedure time) and safety (complication: Gastrointestinal bleeding and perforation) were assessed.
resection was performed in all patients. Four patients had delayed bleeding (3.8%) and two had perforation (1.9%). No significant differences in resection rate (conventional group: 100%, clip flap group: 100%), curative endoscopic resection rate (conventional group: 90.9%, clip flap group: 89.8%, = 0.85), procedure time (conventional group: 70.8 ± 46.2 min, clip flap group: 74.7 ± 53.3 min, = 0.69), area of resected specimen (conventional group: 884.6 ± 792.1 mm, clip flap group: 1006.4 ± 1004.8 mm, = 0.49), delayed bleeding rate (conventional group: 5.5%, clip flap group: 2.0%, = 0.49), or perforation rate (conventional group: 1.8%, clip flap group: 2.0%, = 0.93) were found between the two groups. Less-experienced endoscopists did not show any differences in procedure time between the two groups.
For patients with early-stage gastric tumors, the clip-flap method has no advantage in efficacy or safety compared with the conventional method.
前瞻性研究夹瓣辅助内镜黏膜下剥离术（ESD）治疗胃肿瘤的疗效和安全性。
本研究于 2015 年 5 月至 2016 年 10 月期间，纳入在日本滋贺医科大学医院接受 ESD 治疗的 104 例胃癌或腺瘤患者。我们采用基于肿瘤位置（胃的上、中、下三分之一）、肿瘤大小（<20mm 或>20mm）和溃疡状态的最小化方法将患者随机分为两组：使用内镜夹（夹瓣组）和不使用内镜夹（常规组）的 ESD。评估治疗效果（手术时间）和安全性（并发症：胃肠道出血和穿孔）。
所有患者均完成了切除。4 例患者发生延迟性出血（3.8%），2 例发生穿孔（1.9%）。两组的切除率（常规组：100%，夹瓣组：100%）、完全切除率（常规组：90.9%，夹瓣组：89.8%，=0.85）、手术时间（常规组：70.8±46.2min，夹瓣组：74.7±53.3min，=0.69）、切除标本面积（常规组：884.6±792.1mm，夹瓣组：1006.4±1004.8mm，=0.49）、延迟性出血率（常规组：5.5%，夹瓣组：2.0%，=0.49）和穿孔率（常规组：1.8%，夹瓣组：2.0%，=0.93）均无显著差异。经验较少的内镜医生在两组的手术时间上也没有差异。
对于早期胃肿瘤患者，夹瓣法在疗效和安全性方面与常规方法相比没有优势。
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