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Selective tissue elevation by pressure for endoscopic mucosal resection of colorectal adenoma: First clinical trial

机译:内镜黏膜切除结直肠腺瘤的压力选择性组织抬高:首次临床试验

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Background: Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection of large lateral spreading tumors currently are technically limited by complications such as bleeding, perforation, and disturbed large procedural sites, leading to incomplete resection and secondary surgery. Further technical improvements are necessary. The authors previously demonstrated the effectiveness of a focused water jet for elevation of the lamina submucosa in animal studies. For the first time, the clinical application of selective tissue elevation by pressure (STEP) for the treatment of colorectal adenomas as a prospective single-arm human trial is presented. Methods: This trial evaluated 59 patients who had primary colorectal adenomas with diameters exceeding 12 mm classified as 0-IIa or 0-IIb according to Paris classification. A submucosal cushion was created with a flexible water jet applicator using the Helix HydroJet. The adenoma was subsequently resected with a mucosal resection snare. All results were recorded. The resected specimens were assessed histologically. Results: A total of 59 patients underwent resection of 70 lesions with a maximum diameter of 80 mm (mean, 27 mm). Submucosal elevation with the water jet dissector was possible in all cases and locations from the pectinate line to the ileocecal valve. Of the 70 lesions, 64 (91%) were resected completely in one session. Histologically, the resected specimens were found to be adenocarcinomas (n = 2, 3%), adenomas with high-grade intraepithelial neoplasia (n = 24, 34%), adenomas with low-grade intraepithelial neoplasia (n = 38, 54%), and hyperplastic polyps (n = 6, 9%). Hemostasis during the resection was necessary in 24 cases (34%). No perforation required surgical intervention. Conclusion: This first clinical trial to analyze STEP technique demonstrated that STEP used to elevate large mucosal lesions in any location is feasible and facilitates EMR for colorectal adenoma.
机译:背景:内镜下黏膜切除术(EMR)和内镜下黏膜下剥离术主要用于横向扩散的大型肿瘤,目前在技术上受到诸如出血,穿孔和较大的手术部位受干扰等并发症的限制,导致不完全切除和二次手术。有必要进行进一步的技术改进。作者先前在动物研究中证明了聚焦水射流对提高黏膜下层黏膜的有效性。作为一项前瞻性单臂人体试验,首次提出了选择性加压组织抬高(STEP)治疗大肠腺瘤的临床应用。方法:该试验评估了59例原发性结直肠腺瘤,其直径超过12毫米,根据巴黎分类分为0-IIa或0-IIb。使用Helix HydroJet使用柔性喷水器制作粘膜下垫。腺瘤随后用粘膜切除圈套器切除。记录所有结果。对切​​除的标本进行组织学评估。结果:总共59例患者接受了70处病灶的切除,最大直径为80毫米(平均27毫米)。从果胶酸盐线到回盲瓣膜的所有情况和位置,都可以使用喷水分离器进行粘膜下抬高。在70个病变中,有64个(91%)在一个疗程中完全切除。从组织学上看,切除的标本为腺癌(n = 2,3%),具有高度上皮内瘤变的腺瘤(n = 24,34%),具有低度上皮内瘤变的腺瘤(n = 38,54%)。和增生性息肉(n = 6,9%)。切除过程中止血24例(34%)是必要的。无需穿孔即可进行手术干预。结论:这项分析STEP技术的首次临床试验表明,STEP用于在任何位置抬高大粘膜病变是可行的,并有助于大肠腺瘤的EMR。

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