Antireflux transoral incisionless fundoplication using EsophyX:: 12-month results of a prospective multicenter study
Antireflux transoral incisionless fundoplication using EsophyX:: 12-month results of a prospective multicenter study
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DOI：
10.1007/s00268-008-9594-9
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发表时间：
2008-08-01
影响因子：
2.6
通讯作者：
Deviere, Jacques
中科院分区：
文献类型：
--
作者：
Cadiere, Guy-Bernard;Buset, Michel;Deviere, Jacques
背景一种新型经口无切口胃底折叠术（TIF），使用EsophyX系统和Serosaedic紧固件，旨在通过在单个器械插入过程中定制输送多个紧固件，在胃食管连接处重建全层瓣膜。方法采用前瞻性多中心临床试验，评价TIF治疗胃食管反流病（GERD）的安全性和有效性。结果TIF手术（n = 84）减少了所有食管裂孔疝（n = 49），并构建了4 cm（2-6 cm）和230 °（160 °-300 °）的瓣膜。严重不良事件包括2例器械插入时食管穿孔和1例术后腔内出血。其他不良事件为轻度和一过性。12个月时，总体（n = 79）和分层Hill I级（n = 21）结果显示，73%和86%的患者GERD健康相关生活质量（HRQL）评分改善≥ 50%，85%的患者停用每日PPI，81%的患者完全停用PPI; 37%和48%的患者食管酸暴露正常化;食管裂孔疝减少分别为60%和89%;食管炎减少分别为62%和80%。超过50%的Hill I级紧瓣膜患者的贲门周长正常化。食管下括约肌（LES）的静息压显著改善（p < 0.001），提高了53%。EsophyX-TIF治愈胃食管反流病在56%的患者的基础上，他们的症状减轻和PPI discontinuation.Conclusions的12个月的结果表明，EsophyX-TIF是安全和有效的改善生活质量和减少症状，PPI的使用，食管裂孔疝，食管炎，以及增加LES静息压和正常化食管pH值和贲门周围的慢性胃食管反流病患者。
Background A novel transoral incisionless fundoplication (TIF) procedure using the EsophyX system with SerosaFuse fasteners was designed to reconstruct a full-thickness valve at the gastroesophageal junction through tailored delivery of multiple fasteners during a single-device insertion. The safety and efficacy of TIF for treating gastroesophageal reflux disease (GERD) were evaluated in a prospective multicenter trial.Methods Patients (n = 86) with chronic GERD treated with proton pump inhibitors (PPIs) were enrolled. Exclusion criteria included an irreducible hiatal hernia > 2 cm.Results The TIF procedure (n = 84) reduced all hiatal hernias (n = 49) and constructed valves measuring 4 cm (2-6 cm) and 230 degrees (160 degrees-300 degrees). Serious adverse events consisted of two esophageal perforations upon device insertion and one case of postoperative intraluminal bleeding. Other adverse events were mild and transient. At 12 months, aggregate (n = 79) and stratified Hill grade I tight (n = 21) results showed 73% and 86% of patients with >= 50% improvement in GERD health-related quality of life (HRQL) scores, 85% discontinuation of daily PPI use, and 81% complete cessation of PPIs; 37% and 48% normalization of esophageal acid exposure; 60% and 89% hiatal hernia reduction; and 62% and 80% esophagitis reduction, respectively. More than 50% of patients with Hill grade I tight valves had a normalized cardia circumference. Resting pressure of the lower esophageal sphincter (LES) was improved significantly (p < 0.001), by 53%. EsophyX-TIF cured GERD in 56% of patients based on their symptom reduction and PPI discontinuation.Conclusions The 12-month results showed that EsophyX-TIF was safe and effective in improving quality of life and for reducing symptoms, PPI use, hiatal hernia, and esophagitis, as well as increasing the LES resting pressure and normalizing esophageal pH and cardia circumference in chronic GERD patients.