内镜下黏膜冷切除术对比内镜下黏膜电热切除术治疗10-20mm无蒂结直肠息肉的随机对照临床研究

A randomized controlled clinical trial of endoscopic cold mucosal resection versus endoscopic electrothermal mucosal resection in the treatment of 10-20mm sessile colorectal polyps

摘要:

【摘要】目的 比较内镜下黏膜冷切除术（Cold-endoscopic mucosal resection，C-EMR）与内镜下黏膜电热切除术（Hot-endoscopic mucosal resection，H-EMR）治疗10-20mm无蒂结直肠息肉的有效性及安全性，为10-20mm的结直肠无蒂息肉治疗方式的选择提供依据。方法 本研究是一项单中心、随机、非劣势性试验设计。根据纳排标准，选取至少患有一个大小10-20mm、巴黎分型Is、IIa型息肉的患者入组，将其随机分为C-EMR组和H-EMR组。C-EMR组不使用高频电流治疗，H-EMR组通过高频电切除息肉。这两种方法都包括粘膜下注射亚甲蓝染色的生理盐水混合溶液。主要观察指标是两组的息肉完全切除率、术后不良事件发生率（出血、穿孔、感染）、息肉复发率。次要观察指标是手术时间和成本效益分析。结果 纳入209例患者中，共有209个符合条件的息肉(C-EMR n=104个，H-EMR n=105个)。两组息肉完全切除率(C-EMR 94.3%，H-EMR 95.2%；P=0.276)、息肉复发率(C-EMR 2.9%，H-EMR 1.9%；P=0.683)及不良事件发生率(C-EMR 5.7%，H-EMR 1.9%；P=0.280)均无统计学差异。相比于H-EMR组，C-EMR组手术时间更短、钛夹使用个数更少，两组有统计学差异（P＜0.05）。结论 C-EMR治疗10-20mm无蒂结直肠息肉的有效性及安全性不劣于H-EMR。C-EMR的广泛开展可能会缩短手术操作时间，降低医疗服务成本和费用。

Abstract:

【Abstract】 Objective To compare Cold-endoscopic mucosal resection (C-EMR) with Hot-endoscopic mucosal resection (hot-endoscopic mucosal resection). To evaluate the efficacy and safety of H-EMR in the treatment of colorectal polyps with a diameter of 10-20mm, and to provide a basis for the selection of treatment methods for colorectal polyps with a diameter of 10-20mm. Methods This study was a single-center, randomized, non-inferiority trial design. According to the inclusion and exclusion criteria, patients with at least one size 10-20mm, Paris type Is, type IIa polyp were selected and randomly divided into C-EMR group and H-EMR group. The C-EMR group was not treated with high-frequency electric current, while the H-EMR group was treated with high-frequency electric current to remove polyps. Both methods involve submucosal injection of a mixture of saline stained with methylene blue. The main outcome measures were the complete resection rate of polyps, the incidence of postoperative adverse events (bleeding, perforation, infection), and the recurrence rate of polyps in the two groups. Secondary outcome measures were procedure time and cost-benefit analysis. Results A total of 209 eligible polyps were included in 209 patients (C-EMR n=104, H-EMR n=105). The complete polyp resection rate (C-EMR 94.3%, H-EMR 95.2%; P=0.276), polyp recurrence rate (C-EMR 2.9%, H-EMR 1.9%; P=0.683) and incidence of adverse events (C-EMR 5.7%, H-EMR 1.9%; P=0.276). Compared with the H-EMR group, the C-EMR group had shorter operation time and fewer titanium clips, and the differences were statistically significant (P < 0.05). Conclusion The efficacy and safety of C-EMR in the treatment of colorectal polyps 10-20mm are not inferior to H-EMR. The widespread development of C-EMR may reduce the cost and expenses of medical services.