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内镜下切除帽与多环黏膜切除术治疗早期 Barrett 黏膜肿瘤分片内镜切除的随机试验。

Randomized trial on endoscopic resection-cap versus multiband mucosectomy for piecemeal endoscopic resection of early Barrett's neoplasia.

机构信息

Department of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.

出版信息

Gastrointest Endosc. 2011 Jul;74(1):35-43. doi: 10.1016/j.gie.2011.03.1243.

DOI:10.1016/j.gie.2011.03.1243
PMID:21704807
Abstract

BACKGROUND

Endoscopic resection (ER) is an important treatment for high-grade intraepithelial neoplasia and early cancer in Barrett's esophagus. ER-cap requires submucosal lifting and positioning of a snare in the cap, making it technically demanding and laborious. Multiband mucosectomy (MBM) uses a modified variceal band ligator and requires no submucosal lifting or positioning of a snare.

OBJECTIVE

To compare ER-cap and MBM for piecemeal ER of early Barrett's neoplasia.

DESIGN

Randomized, controlled trial.

SETTING

Tertiary-care and community-care centers.

PATIENTS

This study involved 84 patients (64 men; median age 70 years) undergoing piecemeal ER of Barrett's neoplasia.

INTERVENTION

Piecemeal ER was performed by using ER-cap (n = 42) or MBM (n = 42).

MAIN OUTCOME MEASUREMENTS

Safety, efficacy, procedure time, costs.

RESULTS

Procedure time (34 vs 50 minutes; P = .02) and costs (€240 vs €322; P < .01) were significantly less with MBM compared with ER-cap. MBM resulted in smaller resection specimens than ER-cap (18 ×13 mm vs 20 × 15 mm; P < .01). Maximum thicknesses of specimens and resected submucosa were not significantly different. There were no clinically relevant bleeding episodes. Four perforations occurred, 3 with ER-cap, 1 with MBM (P = not significant).

LIMITATIONS

Potential bias because of different levels of experience among participating endoscopists.

CONCLUSION

Piecemeal ER with MBM is faster and cheaper than with ER-cap. Despite the lack of submucosal lifting, MBM appears not to be associated with more perforations. Although MBM results in slightly smaller specimens, the clinical relevance of this may be limited because depth of resections does not differ between both techniques. MBM may thus be preferred for piecemeal ER of early Barrett's neoplasia. (

CLINICAL TRIAL REGISTRATION NUMBER

NTR1435.).

摘要

背景

内镜下切除术(ER)是 Barrett 食管高级别上皮内瘤变和早期癌的重要治疗方法。ER 帽需要黏膜下抬举和圈套器在帽内定位,因此技术要求高且繁琐。多环黏膜切除术(MBM)使用改良的食管静脉曲张套扎器,不需要黏膜下抬举或圈套器定位。

目的

比较 ER 帽和 MBM 在 Barrett 早期肿瘤的分片式 ER 中的应用。

设计

随机对照试验。

设置

三级和社区医疗中心。

患者

这项研究纳入了 84 例(64 例男性;中位年龄 70 岁)接受 Barrett 肿瘤分片式 ER 的患者。

干预措施

采用 ER 帽(n = 42)或 MBM(n = 42)进行分片式 ER。

主要观察指标

安全性、疗效、手术时间、费用。

结果

与 ER 帽相比,MBM 的手术时间(34 分钟 vs 50 分钟;P =.02)和费用(€240 比 €322;P <.01)显著降低。MBM 切除标本的尺寸小于 ER 帽(18×13mm 比 20×15mm;P <.01)。标本的最大厚度和切除的黏膜下层无显著差异。无临床相关的出血事件。4 例穿孔,3 例与 ER 帽有关,1 例与 MBM 有关(P = 无显著差异)。

局限性

由于参与内镜医生的经验水平不同,可能存在偏倚。

结论

MBM 分片式 ER 比 ER 帽更快、更便宜。尽管没有黏膜下抬举,MBM 似乎与更多穿孔无关。尽管 MBM 产生的标本稍小,但由于两种技术的切除深度没有差异,其临床相关性可能有限。因此,MBM 可能更适合 Barrett 早期肿瘤的分片式 ER。(

临床试验注册号

NTR1435。)。

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