Filipi C J, Lehman G A, Rothstein R I, Raijman I, Stiegmann G V, Waring J P, Hunter J G, Gostout C J, Edmundowicz S A, Dunne D P, Watson P A, Cornet D A
Department of Surgery, Creighton University, Omaha, Nebraska 68131, USA.
Gastrointest Endosc. 2001 Apr;53(4):416-22. doi: 10.1067/mge.2001.113502.
A totally transoral outpatient procedure for the treatment of GERD would be appealing.
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.
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.
Endoscopic gastroplasty is safe. It is associated with reduced symptoms and medication use at 6 month follow-up in patients with uncomplicated GERD.
一种完全经口的门诊手术治疗胃食管反流病（GERD）将会很有吸引力。
启动了一项多中心试验，纳入64例接受内镜缝合装置治疗的GERD患者。纳入标准为每周有3次或更多次烧心发作且未服用药物、依赖抗分泌药物以及通过pH监测记录有酸反流。排除标准为吞咽困难、3级或4级食管炎、肥胖以及长度大于2 cm的食管裂孔疝。患者在手术前后接受测压、内镜检查、24小时pH监测以及症状严重程度评分。患者被随机分为线性或环形折叠构型。记录手术相关不良事件。
平均6个月的症状评分变化显示了手术疗效。烧心的严重程度和频率以及反流均有所改善（每项p>0.0001）。24小时pH监测显示在3个月和6个月时pH低于4的发作次数有所改善（p<0.0007和0.0002），在6个月时pH小于4的总时间百分比有所改善（p<0.011）。折叠构型不影响症状或pH监测结果。1例患者发生了独立的缝合穿孔，经抗生素治疗成功。
内镜胃成形术是安全的。在6个月随访时，它与单纯性GERD患者症状减轻和药物使用减少相关。
