夹瓣法辅助胃肿瘤内镜黏膜下剥离的安全性和有效性研究

The Safety and Effectiveness of the Endoscopic Submucosal Dissection for Gastric Tumor Using the Clip-Flap Method

目的采用前瞻性随机对照试验设计探讨金属钛夹辅助内镜黏膜下剥离术(ESD)治疗胃肿瘤的安全有效性。方法纳入我院2019年10月至2021年2月,择期ESD治疗胃肿瘤患者156例。根据肿瘤位置(胃上、中、下1/3)和肿瘤大小(≤2 cm或>2 cm),随机分为使用金属钛夹组(夹瓣法组)和不使用金属钛夹组(对照组)。术后评价安全性(迟发性出血和穿孔)和有效性(整体切除率,根治性内镜切除率,手术时间)。结果最终纳入143例患者,夹瓣法组72例,对照组71例。两组迟发性出血、穿孔、整体切除率、根治性内镜切除率、手术时间比较,差异无统计学意义(P>0.05)。不同肿瘤大小(≤2 cm或>2 cm)和肿瘤部位(上、中、下)的手术时间差异有统计学意义。组间比较,夹瓣法组>1 cm,≤2 cm及>2 cm肿瘤手术时间均短于对照组,夹瓣法组胃上1/3手术时间短于对照组,差异有统计学意义(P<0.05)。组内比较,夹瓣法组和对照组>2 cm肿瘤手术时间均长于≤1 cm肿瘤手术时间,夹瓣法组和对照组胃上1/3手术时间均长于胃下1/3手术时间,差异有统计学意义(P<0.05)。结论早期胃肿瘤患者选择金属钛夹辅助ESD,总体安全性及有效性无明显优势;使用金属钛夹辅助ESD后,同样存在>2 cm胃肿瘤和胃上1/3肿瘤手术时间更长,但可缩短>1 cm胃肿瘤及胃上1/3肿瘤手术时间。

Objective A prospective randomized controlled trial design was used to explore the safety and effectiveness of endoscopic submucosal dissection(ESD) for gastric tumor using the clip-flap method.Methods 156 patients with gastric tumors undergoing ESD were enrolled in our hospital from October 2019 to February 2021.According to the tumor location(upper,middle,and low 1/3 of the stomach) and tumor size(≤2 cm or>2 cm),patients were randomly divided into using metal titanium clamp group(clip-flap method group) and no using clamp group(control group).Postoperative evaluation of safety(delayed bleeding and perforation) and effectiveness(total resection rate,radical endoscopic resection rate,procedure length) were recorded.Results 143 patients underwent final analysis,with 72 patients in the clip-flap method group and 71 patients in the control group.There was no significant difference in delayed bleeding,perforation,overall resection rate,radical endoscopic resection rate,and procedure length(P>0.05).There were statistically significant differences in procedure length concerning size and site of gastric tumors.Comparison between groups showed that the procedure lengths of gastric tumors>1 cm,≤2 cm and>2 cm in the clip-flap method group were shorter than those in the control group,and the procedure lengths of gastric tumor locating at upper 1/3 in the clip-flap method group were shorter than those in the control group(P<0.05).Comparing the clip-flap method group and the control group,the procedure length of gastric tumors>2 cm were longer than those of ≤1 cm tumors,and the procedure lengths of the gastric tumor locating at upper 1/3 of were significantly longer than those locating at low 1/3(P<0.05).Conclusion There is no obvious advantage in overall safety and effectiveness in patients with gastric tumor undergoing endoscopic submucosal dissection using the clip-flap method.Procedure lengths of gastric tumors>2 cm and gastric tumors locating at upper are still longer than others after using the clip-flap method,but they can be shortened in gastric tumors>1 cm and gastric tumor locating at upper 1/3.