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用于诊断严重肠道通畅性的M2A通畅胶囊的安全性和有效性:一项前瞻性临床试验的结果

Safety and efficacy of the M2A patency capsule for diagnosis of critical intestinal patency: results of a prospective clinical trial.

作者信息

Banerjee Rupa, Bhargav Prem, Reddy Praveen, Gupta Rajesh, Lakhtakia Sandeep, Tandan Manu, Rao Venkat G, Reddy Nageshwar D

机构信息

Asian Institute of Gastroenterology, Hyderabad, Andhra Pradesh, India.

出版信息

J Gastroenterol Hepatol. 2007 Dec;22(12):2060-3. doi: 10.1111/j.1440-1746.2007.05039.x. Epub 2007 Jul 5.

DOI:10.1111/j.1440-1746.2007.05039.x
PMID:17614957
Abstract

BACKGROUND AND AIM

The presence of a critical intestinal stricture is a contraindication for conventional capsule endoscopy for the risk of impaction. Prior assessment of intestinal patency can substantially minimize this risk. The aim of the present study was to assess the safety and efficacy of the M2A patency capsule (PC) for verification of intestinal strictures.

METHODS

The M2A PC consists of a biodegradable body surrounding a small radiofrequency identification (RFID) tag. This capsule was administered to patients with known or suspected intestinal strictures. Patency was verified if the capsule was excreted intact. The capsule disintegrated into small fragments and only the RFID tag was excreted if retained at the stricture beyond a stipulated time. The patency scanner was used to detect the RFID tag externally. The M2A video capsule (VC) was administered to patients who excreted the intact capsule.

RESULTS

Twenty-six patients with known or suspected intestinal strictures were administered the M2A PC. This included 16 (61%) patients with tuberculosis, eight (31%) with Crohn's disease, and one each of postoperative and malignant strictures. Eight capsules were excreted intact within 72 h and two at 109 and 110 h. Fifteen capsules disintegrated in the G(I) tract and one capsule was removed during surgery. No PC-related complications were noted. Six of the eight patients who tested positive for patency were tested with the regular M2A VC with normal excretion.

CONCLUSION

The M2A PC is a reliable indicator of functional patency in suspected or even known cases of intestinal stricture. It could be used prior to conventional capsule endoscopy to predict and minimize the risk of impaction.

摘要

背景与目的

存在严重肠道狭窄是常规胶囊内镜检查的禁忌证,因为有胶囊嵌顿的风险。术前评估肠道通畅情况可大幅降低此风险。本研究的目的是评估M2A通畅性胶囊(PC)用于验证肠道狭窄的安全性和有效性。

方法

M2A PC由包裹着一个小型射频识别(RFID)标签的可生物降解主体组成。将该胶囊给予已知或疑似肠道狭窄的患者。如果胶囊完整排出,则证实肠道通畅。如果胶囊在狭窄部位滞留超过规定时间,则会分解成小碎片,只有RFID标签排出。使用通畅性扫描仪从外部检测RFID标签。将M2A视频胶囊(VC)给予排出完整胶囊的患者。

结果

26例已知或疑似肠道狭窄的患者接受了M2A PC检查。其中包括16例(61%)结核病患者、8例(31%)克罗恩病患者,以及1例术后狭窄和1例恶性狭窄患者。8枚胶囊在72小时内完整排出,2枚分别在109小时和110小时排出。15枚胶囊在胃肠道内分解,1枚胶囊在手术中取出。未发现与PC相关的并发症。8例通畅性检测呈阳性的患者中有6例接受了常规M2A VC检查,胶囊排出正常。

结论

M2A PC是疑似甚至已知肠道狭窄病例中功能通畅性的可靠指标。它可在常规胶囊内镜检查前使用,以预测并降低胶囊嵌顿的风险。

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