Harsányi László, Kincses Zsolt, Veselinović Milan, Zehetner Joerg, Altorjay Áron
Department of Surgery, Transplantation and Gastroenterology, Semmelweis University, Budapest, Hungary.
The Department of Surgery Kenezy Campus, Clinical Center of the University of Debrecen Teaching Hospital, Debrecen, Hungary.
Surg Endosc. 2025 Jul 22. doi: 10.1007/s00464-025-11979-9.
INTRODUCTION: RefluxStop surgery corrects all three components of the anti-reflux barrier without affecting the food passageway. Long-term 5-year safety and effectiveness clinical outcomes are presented from the RefluxStop CE mark trial, used in an FDA PMA submission. This comprehensive and meticulously controlled data are, therefore, presented across multiple reports with other outcomes in a separate complementary article. METHODS: A prospective, single-arm, multicenter clinical study was conducted to investigate RefluxStop surgery in 50 adults with chronic GERD, PPI use, GERD-HRQL score, 24-h pH testing, contrast-swallow x-ray, and serious/non-serious AEs presented. RESULTS: Forty-four (n = 44) subjects completed 5-year follow-up, whereof 91% underwent pH testing and contrast-swallow x-ray. Three subjects were withdrawn due to COVID-19 (two deaths and one long-COVID), all well-treated beforehand, at 3-4 years. PPI usage (including COVID-19 subjects) in 1/47 (2.1%). The median (IQR) total GERD-HRQL score improved by 90% (72-98%) from a baseline of 29.5 (33.0-24.0) to 3.0 (0.5-7.5) at 5 years (p < 0.001) and 24-h pH monitoring results improved by 90.4% to a mean total acid exposure time (pH < 4) of 1.57% from 16.35% at baseline (p < 0.001). No cases (0%) of device explantation, migration/erosion, or esophageal dilatation occurred during the study. Five-year contrast-swallow x-ray showed zero (0%) dislocations, migrations, or re-herniations. Five subjects (n = 5) experienced serious AEs of which all were resolved. Only two procedure-related AEs occurred between 1 and 5 years, one moderate dyspepsia and one mild dysphagia, subsequently resolved. CONCLUSION: The RefluxStop procedure demonstrated exceptional long-term 5-year outcomes. Only one subject took PPIs at follow-up. Both median GERD-HRQL scores and mean 24-h pH results improved by > 90% from baseline (p = 0.001). No device-related AEs, explantations, or migrations occurred during the 5-year study. Only two procedure-related AEs occurred between 1 and 5 years, one dyspepsia and one mild dysphagia (resolved). These objective and patient-reported results were robustly maintained from previously published 1- to 4-year data.
引言：反流停止手术可纠正抗反流屏障的所有三个组成部分，而不影响食物通道。本文展示了反流停止CE标志试验的5年长期安全性和有效性临床结果，该试验用于美国食品药品监督管理局（FDA）的上市前批准申请（PMA）。因此，这些全面且经过精心控制的数据将在多篇报告中呈现，其他结果将在另一篇补充文章中阐述。 方法：开展了一项前瞻性、单臂、多中心临床研究，对50名患有慢性胃食管反流病（GERD）的成年人进行反流停止手术，记录了质子泵抑制剂（PPI）使用情况、GERD健康相关生活质量（GERD-HRQL）评分、24小时pH值检测、吞钡造影X线检查以及严重/非严重不良事件。 结果：44名受试者完成了5年随访，其中91%接受了pH值检测和吞钡造影X线检查。3名受试者因新冠疫情退出研究（2例死亡，1例长期新冠症状），他们在3至4年时均接受了良好治疗。47名受试者中仅有1名（2.1%）使用PPI（包括新冠疫情相关受试者）。5年时，GERD-HRQL总分中位数（四分位间距）从基线的29.5（33.0 - 24.0）改善了90%（72 - 98%）至3.0（0.5 - 7.5）（p < 0.001），24小时pH值监测结果从基线的16.35%改善了90.4%至平均总酸暴露时间（pH < 4）为1.57%（p < 0.001）。研究期间未发生器械取出、移位/侵蚀或食管扩张的病例（0%）。5年吞钡造影X线检查显示无（0%）脱位、移位或复发疝。5名受试者经历了严重不良事件，所有事件均得到解决。1至5年间仅发生2例与手术相关的不良事件，1例中度消化不良和1例轻度吞咽困难，随后均得到解决。 结论：反流停止手术显示出卓越的5年长期效果。随访时仅有1名受试者使用PPI。GERD-HRQL总分中位数和平均24小时pH值结果均较基线改善超过90%（p = 0.001）。5年研究期间未发生与器械相关的不良事件、取出或移位。1至5年间仅发生2例与手术相关的不良事件，1例消化不良和1例轻度吞咽困难（已解决）。这些客观结果和患者报告结果与之前发表的1至4年数据一致且稳固。
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