Magnetic Augmentation of the Lower Esophageal Sphincter: Results of a Feasibility Clinical Trial
Magnetic Augmentation of the Lower Esophageal Sphincter: Results of a Feasibility Clinical Trial
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DOI：
10.1007/s11605-008-0698-1
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发表时间：
2008-12-01
影响因子：
3.2
通讯作者：
DeMeester, Tom
中科院分区：
文献类型：
--
作者：
Bonavina, Luigi;Saino, Greta I.;DeMeester, Tom
胃食道反流病的高患病率继续鼓励开发治疗方式，以填补抑酸治疗和腹腔镜Nissen胃底折叠术之间的空白。磁性括约肌增强器的设计是利用磁力来增强下食道括约肌屏障。为了评估安全性和有效性，进行了一项多中心可行性试验，纳入了典型的胃灼热(至少对质子泵抑制剂有部分反应)、食管酸暴露异常和食道蠕动正常的患者。患有裂孔疝气3厘米的患者被排除在研究之外。在1年的时间里，在3家医院的41名登记患者中，38名患者接受了这一手术。无手术并发症发生。术后第1天开始免费饮食，97%的患者在48h内出院，平均随访209d(12~434d)。GERD-HRQL评分从26.0分降至1.0分(p<；0.005)。术后3个月，%的患者停用抗反流药物，79%的患者24小时pH值正常。所有患者均保留了打嗝的能力。45%的患者出现轻度吞咽困难。该装置未发生移位或侵蚀。腹腔镜下植入MSA装置是安全和耐受性良好的。与传统的尼森胃底折叠术相比，它需要最小的手术解剖和较短的学习曲线。
The high prevalence of gastroesophageal reflux disease continues to encourage the development of treatment modalities to fill the gap between acid-suppression therapy and the laparoscopic Nissen fundoplication. The Magnetic Sphincter Augmentation device has been designed to augment the lower esophageal sphincter barrier using magnetic force. A multi-center feasibility trial was done to evaluate safety and efficacy.Patients with typical heartburn (at least partially responding to proton-pump inhibitors), abnormal esophageal acid exposure, and normal esophageal peristalsis were enrolled. Patients with hiatal hernia > 3 cm were excluded from the study. The device was implanted laparoscopically around the distal esophagus.Over a 1-year period, 38 out of 41 enrolled patients underwent this procedure in 3 hospitals. No operative complications were recorded. A free diet was allowed since post-operative day one, and 97% of patients were discharged within 48 h. The mean follow-up was 209 days (range 12-434 days). The GERD-HRQL score decreased from 26.0 to 1.0 (p < 0.005). At 3 months post-operatively, 89% of patients were off anti-reflux medications, and 79% of patients had a normal 24-h pH test. All patients preserved the ability to belch. Mild dysphagia occurred in 45% of patients. No migrations or erosions of the device occurred.Laparoscopic implant of the MSA device is safe and well tolerated. It requires minimal surgical dissection and a short learning curve compared to the conventional Nissen fundoplication.