Department of Gastroenterology and Digestive Endoscopy, IRCCS Istituto Clinico Humanitas, 20089 Milan, Italy.
J Gastrointest Surg. 2010 Jan;14(1):1-6. doi: 10.1007/s11605-009-1077-2. Epub 2009 Nov 10.
Several endoscopic antireflux therapies have been proposed to reduce the need for chronic medical therapy or laparoscopic fundoplication for gastroesophageal reflux disease (GERD). Aim of this study was to evaluate the short- and mid-term clinical results of endoluminal fundoplication (ELF) with EsophyX.
From June 2006 to April 2008, 20 patients were enrolled in the study. All the ELFs were performed under general anesthesia.
The mean duration of the procedure was 63 min (range 38-105). A median of 14 fasteners was placed. There were no major intraoperative complications. Two patients developed early complications and were treated conservatively. Four patients underwent, within the first year post-ELF, a laparoscopic fundoplication because of persistence of symptoms. One patient was lost to follow-up between 6 and 12 months. Among the other 15 patients who completed 12 months follow-up, the GERD health-related quality of life score decreased from a median of 40 to a median of 10 (p < 0.05), and seven patients were still off proton pump inhibitor. An improvement in esophageal acid exposure was recorded in 16.6% of patients, while in 66.7%, it worsened.
ELF induced improvement of GERD symptoms and patients quality of life in a subgroup of patients with a reduced need for medication. However, it did not significantly change esophageal acid exposure in these patients. The need for revisional standard laparoscopic fundoplication was high.
已经提出了几种内镜抗反流治疗方法，以减少胃食管反流病（GERD）患者对慢性药物治疗或腹腔镜胃底折叠术的需求。本研究的目的是评估 EsophyX 内镜胃底折叠术（ELF）的短期和中期临床效果。
从 2006 年 6 月至 2008 年 4 月，共纳入 20 例患者进行研究。所有 ELF 均在全身麻醉下进行。
手术平均持续时间为 63 分钟（范围 38-105 分钟）。中位数放置 14 个紧固件。术中无重大并发症。两名患者发生早期并发症并接受保守治疗。四名患者在 ELF 后一年内因症状持续而接受腹腔镜胃底折叠术。一名患者在 6-12 个月随访期间失访。在完成 12 个月随访的其他 15 名患者中，GERD 健康相关生活质量评分从中位数 40 降至中位数 10（p < 0.05），7 名患者仍停用质子泵抑制剂。在 16.6%的患者中观察到食管酸暴露改善，而在 66.7%的患者中则恶化。
ELF 可改善 GERD 症状和患者生活质量，减少药物需求，但对这些患者的食管酸暴露无明显影响。需要进行标准腹腔镜胃底折叠术修正的患者比例较高。
