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经内镜黏膜切除术切除结直肠腺瘤的选择性组织抬高压法:首次临床试验。

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

机构信息

Medical Center Mannheim, Medical Department, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.

出版信息

Surg Endosc. 2012 Feb;26(2):343-9. doi: 10.1007/s00464-011-1873-0. Epub 2011 Oct 13.

Abstract

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.

摘要

背景

内镜黏膜切除术(EMR)和内镜黏膜下剥离术治疗大型侧向扩展肿瘤目前受到出血、穿孔和大面积手术部位紊乱等并发症的技术限制,导致切除不完全和二次手术。需要进一步的技术改进。作者之前在动物研究中证明了聚焦水射流用于提升黏膜下层的有效性。本文首次报道了选择性组织提升压力(STEP)技术在治疗结直肠腺瘤中的临床应用,这是一项前瞻性单臂人体试验。

方法

该试验评估了 59 名患有原发性结直肠腺瘤的患者,这些腺瘤的直径超过 12mm,根据巴黎分类标准分为 0-IIa 或 0-IIb 级。使用 Helix HydroJet 柔性水射流应用器创建黏膜下垫。随后使用黏膜切除圈套器切除腺瘤。所有结果均记录。切除标本进行组织学评估。

结果

共有 59 名患者接受了 70 个最大直径为 80mm(平均 27mm)病变的切除术。水射流剥离器能够在从梳状线到回盲瓣的所有部位和位置进行黏膜下抬高。在 70 个病变中,64 个(91%)一次性完全切除。组织学上,切除标本发现为腺癌(n=2,3%)、高级别上皮内瘤变的腺瘤(n=24,34%)、低级别上皮内瘤变的腺瘤(n=38,54%)和增生性息肉(n=6,9%)。在 24 例(34%)中需要止血。没有穿孔需要手术干预。

结论

这是首次分析 STEP 技术的临床试验表明,STEP 用于提升任何部位的大型黏膜病变是可行的,并有助于结直肠腺瘤的 EMR。

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