Department of Surgery, University of Washington, 1959 N.E. Pacific St, 356410, Seattle, WA 98195, USA.
Surg Endosc. 2012 Apr;26(4):1021-7. doi: 10.1007/s00464-011-1989-2. Epub 2011 Nov 1.
There are limited studies that evaluate the efficacy of endoscopic fundoplication (EF) for gastroesophageal reflux disease (GERD) with the EsophyX™ device, especially with the most recent procedural iteration (TIF-2). This study was a prospective evaluation of our early experience with this device and procedure.
Data were collected prospectively on 23 consecutive patients undergoing EF (March 2009 to August 2010). All patients completed a symptom questionnaire assessing frequency and severity of gastrointestinal and respiratory symptoms, 24-h pH, and manometry studies preoperatively and were encouraged to repeat these at 6 months.
All patients had abnormal pH studies and were on proton-pump inhibitor (PPI) therapy prior to EF. Median age was 47 years (19-62 years), and six (23%) were male. Nine (41%) patients had Body Mass Index (BMI) ≥ 30 kg/m(2), and three (14%) had a small hiatal hernia (≤ 2 cm). The procedure was aborted in two patients for retained food. Three patients underwent subsequent laparoscopic Nissen fundoplication for persistent or recurrent symptoms. Median hospitalization was 1 day, and there were no major perioperative complications. At 6 month follow-up, 19 (86%) patients completed a symptom questionnaire, and 14 (64%) and 11 (50%) patients underwent pH and manometry studies, respectively. There was a significant reduction in heartburn (P = 0.02), total percentage acid contact time (P = 0.002), DeMeester score (P = 0.002), and PPI use (P = 0.003). Overall, 8 out of 14 (57%) patients had abnormal pH studies and 11 out of 19 (58%) remained on PPI therapy at 6 months.
EF with EsophyX™ is associated with significant reduction in heartburn and abnormal acid exposure at 6 months, although the majority of patients did not experience normalization of their pH studies and remained on PPI therapy. The procedure has an acceptable safety profile, but the question remains as to whether it is effective enough to warrant a place in the armamentarium for the treatment of GERD.
评估 EsophyX™ 内镜胃底折叠术（EF）治疗胃食管反流病（GERD）的疗效的研究较少，尤其是对于最近的程序迭代（TIF-2）。本研究前瞻性评估了我们在该设备和程序方面的早期经验。
2009 年 3 月至 2010 年 8 月，连续 23 例接受 EF 治疗的患者前瞻性收集数据。所有患者均完成了一项胃肠道和呼吸道症状频率和严重程度的症状问卷评估、24 小时 pH 值和测压研究，并鼓励他们在 6 个月时重复这些检查。
所有患者的 pH 值研究均异常，在 EF 治疗前均接受质子泵抑制剂（PPI）治疗。中位年龄为 47 岁（19-62 岁），其中 6 名（23%）为男性。9 名（41%）患者的 BMI≥30kg/m2，3 名（14%）患者存在小的食管裂孔疝（≤2cm）。由于食物残留，有 2 例患者中止了手术。3 例患者因持续性或复发性症状行后续腹腔镜 Nissen 胃底折叠术。中位住院时间为 1 天，无重大围手术期并发症。6 个月随访时，19 例（86%）患者完成了症状问卷，14 例（64%）和 11 例（50%）患者分别进行了 pH 值和测压研究。烧心症状明显减少（P=0.02），总酸接触时间百分比（P=0.002）、DeMeester 评分（P=0.002）和 PPI 使用（P=0.003）也显著降低。总的来说，14 例患者中有 8 例（57%）pH 值检查异常，19 例患者中有 11 例（58%）在 6 个月时仍在使用 PPI 治疗。
使用 EsophyX™ 的 EF 在 6 个月时与烧心症状显著减少和异常酸暴露有关，但大多数患者的 pH 值检查未恢复正常，仍在使用 PPI 治疗。该程序具有可接受的安全性，但仍存在争议，即它是否足够有效，值得在 GERD 的治疗手段中占有一席之地。
