Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, Telangana, India
Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, Telangana, India.
Gut. 2022 Apr;71(4):686-694. doi: 10.1136/gutjnl-2020-321811. Epub 2021 Apr 13.
The majority of endoscopic antireflux procedures for GERD are cumbersome to use and randomised long-term data are sparse. We conducted such a trial to determine the efficacy and safety of a novel, easy to use endoscopic full-thickness fundoplication (EFTP) device in patients with GERD.
Patients with proton pump inhibitor (PPI)-dependent GERD were randomised to either EFTP or a sham procedure in 1:1 ratio. The primary endpoint was ≥50% improvement in the health-related quality of life (GERD-HRQL) score at 3 months. Secondary end points included improvement in GERD-HRQL, reflux symptom scores, PPI usage, oesophageal acid exposure and reflux episodes and endoscopic findings at 3, 6 and 12 months.
Seventy patients were randomised; 35 in each group with a median (IQR) age of 36 (29-42) years, 71.4% males. 70% had non-erosive reflux disease on endoscopy with a mean DeMeester score of 18.9 (±19.93). The mean (±SD) duration of EFTP procedure was 17.4 (±4) min. The primary end point was more frequently achieved in the EFTP group (65.7% vs 2.9%; p<0.001). Median (IQR) % improvement in GERD-HRQL was significantly higher in the EFTP group at 6 (81.4 (60.9-100.0) versus 8.0 (2.2-21.6); p<0.001) and 12 (92.3 (84.4-100.0) versus 9.1 (4.8-36.0); p<0.001) months. In the EFTP group, 62.8% patients were off-PPI at 12 months compared with 11.4% in the sham group (p<0.001). pH-metry parameters partially improved at 3 months, (n=70; total reflux episodes in EFTP arm and non-acid reflux episodes for EFTP vs sham) but not at 12 months (n=27); endoscopic oesophagitis was seen in 0% in the treatment (n=18) and 5 (29.4%) in the control group (n=17) at 12 months. No major procedure-related adverse events were encountered in either group.
EFTP using a novel device is safe and effective in improving quality of life in patients with PPI dependent mostly non-erosive reflux disease at short and long terms; objective parameters showed a limited response rate.
NCT03322553.
大多数用于 GERD 的内镜抗反流手术使用起来都很繁琐，且长期随机数据稀缺。我们进行了这样一项试验，以确定一种新型、易于使用的内镜全层胃底折叠术（EFTP）在 GERD 患者中的疗效和安全性。
质子泵抑制剂（PPI）依赖型 GERD 患者按 1:1 比例随机分为 EFTP 组或假手术组。主要终点为 3 个月时健康相关生活质量（GERD-HRQL）评分改善≥50%。次要终点包括 GERD-HRQL、反流症状评分、PPI 使用、食管酸暴露和反流次数以及内镜发现的改善，在 3、6 和 12 个月进行评估。
70 例患者被随机分组；每组 35 例，中位（IQR）年龄 36（29-42）岁，71.4%为男性。70%的患者内镜下有非糜烂性反流病，平均 DeMeester 评分 18.9（±19.93）。EFTP 手术的平均（±SD）时间为 17.4（±4）min。EFTP 组主要终点的发生率更高（65.7% vs 2.9%；p<0.001）。EFTP 组 6 个月（81.4（60.9-100.0） vs 8.0（2.2-21.6）；p<0.001）和 12 个月（92.3（84.4-100.0） vs 9.1（4.8-36.0）；p<0.001）时 GERD-HRQL 的中位（IQR）%改善均显著更高。EFTP 组 62.8%的患者在 12 个月时停用 PPI，而假手术组为 11.4%（p<0.001）。pH 监测参数在 3 个月时部分改善（n=70；EFTP 组总的反流次数和 EFTP 组非酸性反流次数与假手术组相比），但在 12 个月时没有改善（n=27）；内镜食管炎在治疗组中为 0%（n=18），在对照组中为 5%（n=17），在 12 个月时观察到。两组均未发生与治疗相关的重大不良事件。
使用新型器械的 EFTP 在短期和长期内安全有效，可改善 PPI 依赖型主要为非糜烂性反流病患者的生活质量；客观参数显示应答率有限。
NCT03322553。
