Transoral, flexible endoscopic suturing for treatment of GERD: a multicenter trial
Transoral, flexible endoscopic suturing for treatment of GERD: a multicenter trial
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DOI：
10.1067/mge.2001.113502
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发表时间：
2001-04-01
影响因子：
7.7
通讯作者：
Cornet, DA
中科院分区：
文献类型：
--
作者：
Filipi, CJ;Lehman, GA;Cornet, DA
背景：一种完全经口的门诊手术治疗胃食管反流是很有吸引力的。方法：开展了一项多中心试验，包括64例使用内镜缝合装置治疗的胃食管反流患者。纳入标准为每周3次或3次以上的烧心发作，但未服用药物，依赖抗分泌药物，并通过pH监测记录胃酸反流。排除标准为吞咽困难、3级或4级食管炎、肥胖和长度大于2cm的裂孔疝。患者在手术前后接受测压、内窥镜检查、24小时pH监测和症状严重程度评分。患者被随机分为线性或周向应用组。记录不良程序事件。结果：平均6个月症状评分变化显示程序有效性。胃灼热严重程度和频率以及反流均有所改善（p < 0.0001）。24小时pH监测显示，3个月和6个月时pH值低于4的发作次数（p < 0.0007和0.0002）和6个月时pH值低于4的总时间百分比（p < 0.011）有所改善。应用程序配置不影响症状或pH值监测结果。一名患者有一个独立的缝合线穿孔，用抗生素成功治疗。结论：内镜下胃成形术是安全的。在无并发症的胃反流患者6个月的随访中，它与症状减轻和药物使用有关。
Background: A totally transoral outpatient procedure far the treatment of GERD would be appealing.Methods: A multicenter trial was initiated that included 64 patients with GERD treated with an endoscopic suturing device. Inclusion criteria were 3 or more heartburn episodes per week while not taking medication, dependency on antisecretory medicine, and documented acid reflux by pH monitoring. Exclusion criteria were dysphagia, grade 3 or 4 esophagitis, obesity, and hiatus hernia greater than 2 cm in length. Patients underwent manometry, endoscopy, 24-hour pH monitoring, and symptom severity scoring before and after the procedure. Patients were randomized to a linear or circumferential plication configuration. Adverse procedural events were recorded.Results: Mean 6-month symptom score changes demonstrated procedural efficacy. Heartburn severity and frequency as well as regurgitation all Improved (p > 0.0001 for each). Twenty-four-hour pH monitoring showed improvement In number of episodes below pH of 4 at 3 and 6 months (p < 0.0007 and 0.0002) and percentage of total time the pH was less than 4 at 6 months (p < 0.011). Plication configuration did not affect symptoms or pH monitoring results. One patient had a self-contained suture perforation that was successfully treated with antibiotics.Conclusion: Endoscopic gastroplasty is safe. It is associated with reduced symptoms and medication use at 6 month follow-up in patients with uncomplicated GERD.