Harsányi László, Kincses Zsolt, Altorjay Áron
Department of Surgery, Transplantation and Gastroenterology, Semmelweis University, Üllői Út 78., Budapest, H-1082, Hungary.
General Surgery Department, University of Debrecen Kenézy Gyula Teaching Hospital, Debrecen, Hungary.
Dig Dis Sci. 2025 Feb;70(2):665-674. doi: 10.1007/s10620-024-08788-w. Epub 2024 Dec 19.
RefluxStop is a unique implant for laparoscopic treatment of gastroesophageal reflux disease (GERD). It restores normal function of the gastroesophageal junction without the unwanted effects of encircling the esophagus, circumventing adverse events (AEs) associated with conventional anti-reflux surgeries.
Three-year follow-up of 50 patients with chronic GERD treated by RefluxStop was achieved in a prospective, single-arm, multicentric clinical trial analyzing safety and effectiveness of the procedure.
The 3-year results included 47 of 50 patients. No cases of device-related AEs, erosion, device migration, or explantation occurred during the entire study period. Two AEs were reported between the 1- and 3-year results (1-year results previously published), including mild dysphagia (n = 1) and heartburn (n = 1). No subjects (n = 0/47) required regular daily proton pump inhibitor (PPI) therapy at 3-year follow-up. Subjects experienced a 93.1% reduction in median total GERD-HRQL score at 3 years (2.0) from baseline (29.5). One subject (n = 1) was dissatisfied with treatment but demonstrated normal 24-h pH monitoring results. Daily regurgitation improved by 97.9% from a baseline of 86% (n = 43/50) to 2.1% (n = 1/47) at follow-up. Dysphagia GERD-HRQL subscore of > 2 (i.e., bothersome everyday) decreased from 22% at baseline to 2% at 3 years. Baseline odynophagia (16%) completely resolved at 3 years.
RefluxStop surgery treats GERD without encircling and applying pressure on the esophagus. Three-year follow-up demonstrates that the device is safe and effective in treating GERD with substantial improvements in quality of life via GERD-HRQL (median improvement 93%), PPI usage (0%), and 98% without dysphagia.
RefluxStop是一种用于腹腔镜治疗胃食管反流病（GERD）的独特植入物。它可恢复胃食管交界处的正常功能，而不会产生环绕食管的不良影响，避免了与传统抗反流手术相关的不良事件（AE）。
在一项前瞻性、单臂、多中心临床试验中，对50例接受RefluxStop治疗的慢性GERD患者进行了为期三年的随访，分析该手术的安全性和有效性。
50例患者中有47例纳入了三年的研究结果。在整个研究期间，未发生与器械相关的不良事件、侵蚀、器械移位或取出情况。在1年和3年的研究结果之间（1年结果先前已发表）报告了2例不良事件，包括轻度吞咽困难（n = 1）和烧心（n = 1）。在三年随访时，没有受试者（n = 0/47）需要每日规律服用质子泵抑制剂（PPI）治疗。受试者在3年时的GERD-HRQL总评分中位数较基线（29.5）降低了93.1%（降至2.0）。1名受试者（n = 1）对治疗不满意，但24小时pH监测结果正常。每日反流情况从基线的86%（n = 43/50）改善至随访时的2.1%（n = 1/47），改善了97.9%。吞咽困难GERD-HRQL子评分>2（即每天都令人烦恼）从基线时的22%降至3年时的2%。基线时的吞咽疼痛（16%）在3年时完全缓解。
RefluxStop手术治疗GERD时不会环绕食管并对其施加压力。三年随访表明，该器械在治疗GERD方面安全有效，通过GERD-HRQL可显著改善生活质量（中位数改善93%），PPI使用率为0%，且98%的患者无吞咽困难。
