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Lower esophageal sphincter injection of a biocompatible polymer: accuracy of implantation assessed by esophagectomy.

机译:食管下括约肌的生物相容性聚合物注射:通过食管切除术评估植入的准确性。

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BACKGROUND: Endoscopic lower esophageal sphincter (LES) implantation of a biocompatible polymer is undergoing clinical trial as an alternative to pharmacologic and laparoscopic treatments for gastroesophageal reflux disease. The safety and efficacy of LES augmentation depend on accurate placement of the implant into the wall of the esophagus. To date, no study has demonstrated the prevalence and location of the intended implant. METHODS: The study group consisted of nine patients with underlying esophageal disease severe enough to warrant esophagectomy. Three or four implants of 1 or 2 cc of Enteryx (a biocompatible ethylene-vinyl alcohol copolymer dissolved in dimethyl sulfoxide with micronized tantalum as a radiopaque marker) were placed at the squamocolumnar junction of each patient via a 4-mm, 23-gauge needle under endoscopic guidance. Fluoroscopy was utilized in all patients to facilitate endoscopic placement. Outcome measures included the prevalence and location of successful implantation into the wall of the esophagus. RESULTS: Thirty of 34 implants (88%) were successfully placed into the wall of the esophagus. The remaining 4 were found lying subserosally or attached to the exterior of the gastroesophageal junction (GEJ). Fluoroscopically, the implants often tended to coalesce, forming arcs or a ring around the GEJ. Histologic examination revealed implantation into the deep submucosa contiguous with the circular muscle and within the muscularis propria in all patients, with implants occasionally extending into the subserosa. There were no untoward reactions identified. CONCLUSIONS: Endoscopically directed implantation of a biocompatible polymer into the esophageal wall can be accomplished with a high degree of accuracy. Injection via a 4-mm needle results in the placement of material along and within the muscular layers of the esophagus.
机译:背景:内窥镜下食管括约肌(LES)生物相容性聚合物的植入正在临床试验中,以替代药物和腹腔镜治疗胃食管反流病。 LES增强的安全性和有效性取决于植入物在食道壁中的准确放置。迄今为止,尚无研究证明预期植入物的患病率和位置。方法:研究组由9名潜在的食管疾病患者组成,这些患者病情严重至需要进行食管切除术。通过4毫米,23口径的针头将3或4立方厘米Enteryx(一种溶解于二甲基亚砜中的生物相容性乙烯-乙烯醇共聚物,以微粉化的钽作为不透射线的标记物)植入每名患者的鳞状小柱交界处,将其植入4针在内窥镜引导下。所有患者均使用荧光镜检查以促进内镜放置。结果措施包括成功植入食管壁的程度和位置。结果:34个植入物中有30个(88%)被成功地放入了食管壁。其余的4个被发现位于浆膜下或附着在胃食管连接处(GEJ)的外部。在荧光镜下,植入物往往趋于合并,在GEJ周围形成弧形或环形。组织学检查显示,所有患者均植入与环形肌相邻的深层粘膜下层,并在固有肌层内植入,植入物偶尔会延伸至浆膜下。没有发现不良反应。结论:内镜引导下的生物相容性聚合物植入食管壁可以高度准确地完成。通过4毫米针头注射会导致沿食道的肌肉层及其内部放置材料。

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