{"title":"Feasibility and efficacy of pH-integrated ultrathin endoscopy for ambulatory gastroesophageal reflux monitoring (with videos).","authors":"Xiaoyu Hu, Yaoping Zhang, Jinyong Hao, Bofu Tang, Yifan Zhang, Xiaojun Huang","doi":"10.1093/gastro/goaf085","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Current techniques for monitoring gastroesophageal reflux are limited to measuring physicochemical parameters. We presented a novel pH-integrated ultrathin endoscope (the EndoMonitor System) for simultaneous acquisition of reflux images and pH data. This preclinical study evaluated the performance of the latest version of the EndoMonitor System.</p><p><strong>Methods: </strong>The stability and hydrogen ion selectivity of the pH electrode in the EndoMonitor System were evaluated. Subsequently, six types of reflux events were simulated in an isolated organ (porcine esophagus-stomach). Complete duodenal ligation was used to create porcine gastroesophageal reflux models. The number of reflux episodes and acid exposure time were assessed and compared with the pH-impedance catheter results.</p><p><strong>Results: </strong>The detection rates for distal acid reflux, distal mixed reflux, and horizontal acid reflux events of the EndoMonitor System were significantly higher than those of the pH-impedance catheter (100% vs 18.6%, 100% vs 32.7%, and 100% vs 49.1%, respectively; all <i>P </i>< 0.001). Furthermore, the EndoMonitor System demonstrated superior detection performance in proximal acid and mixed reflux events compared with the pH-impedance catheter (100% vs 90.9% and 100% vs 88.1%, respectively; both <i>P </i>< 0.05). <i>In vivo</i> reflux monitoring demonstrated statistically higher detection rates of reflux events with the EndoMonitor System in two-thirds of the experimental groups (<i>P </i>< 0.05), with a more remarkable overall detection advantage (100% vs 82.0%; <i>P </i>< 0.001). The acid exposure time measurement results for these two devices were comparable (mean ± standard deviation: 2.62 ± 1.82 vs 2.52 ± 1.74 min; <i>P </i>= 0.161).</p><p><strong>Conclusions: </strong>The EndoMonitor System improves the accuracy of identifying reflux events and simplifies the monitoring process. It was also highly operable. This study provided important preclinical experience for clinical trials.</p>","PeriodicalId":54275,"journal":{"name":"Gastroenterology Report","volume":"13 ","pages":"goaf085"},"PeriodicalIF":4.2000,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12448187/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Gastroenterology Report","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/gastro/goaf085","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Current techniques for monitoring gastroesophageal reflux are limited to measuring physicochemical parameters. We presented a novel pH-integrated ultrathin endoscope (the EndoMonitor System) for simultaneous acquisition of reflux images and pH data. This preclinical study evaluated the performance of the latest version of the EndoMonitor System.
Methods: The stability and hydrogen ion selectivity of the pH electrode in the EndoMonitor System were evaluated. Subsequently, six types of reflux events were simulated in an isolated organ (porcine esophagus-stomach). Complete duodenal ligation was used to create porcine gastroesophageal reflux models. The number of reflux episodes and acid exposure time were assessed and compared with the pH-impedance catheter results.
Results: The detection rates for distal acid reflux, distal mixed reflux, and horizontal acid reflux events of the EndoMonitor System were significantly higher than those of the pH-impedance catheter (100% vs 18.6%, 100% vs 32.7%, and 100% vs 49.1%, respectively; all P < 0.001). Furthermore, the EndoMonitor System demonstrated superior detection performance in proximal acid and mixed reflux events compared with the pH-impedance catheter (100% vs 90.9% and 100% vs 88.1%, respectively; both P < 0.05). In vivo reflux monitoring demonstrated statistically higher detection rates of reflux events with the EndoMonitor System in two-thirds of the experimental groups (P < 0.05), with a more remarkable overall detection advantage (100% vs 82.0%; P < 0.001). The acid exposure time measurement results for these two devices were comparable (mean ± standard deviation: 2.62 ± 1.82 vs 2.52 ± 1.74 min; P = 0.161).
Conclusions: The EndoMonitor System improves the accuracy of identifying reflux events and simplifies the monitoring process. It was also highly operable. This study provided important preclinical experience for clinical trials.
背景：目前监测胃食管反流的技术仅限于测量物理化学参数。我们提出了一种新型的pH集成超薄内窥镜（EndoMonitor系统），用于同时获取回流图像和pH数据。这项临床前研究评估了最新版本EndoMonitor系统的性能。方法：评价pH电极在EndoMonitor系统中的稳定性和氢离子选择性。随后，在分离的器官（猪食管-胃）中模拟了六种类型的反流事件。采用完全十二指肠结扎法建立猪胃食管反流模型。评估反流发作次数和酸暴露时间，并与ph阻抗导管结果进行比较。结果：EndoMonitor System对远端酸反流、远端混合酸反流和水平酸反流事件的检出率均显著高于ph阻抗导管（100% vs 18.6%、100% vs 32.7%、100% vs 49.1%）；所有P P体内反流监测显示，三分之二的实验组使用EndoMonitor System对反流事件的检出率具有统计学意义（P P P = 0.161）。结论：EndoMonitor系统提高了识别反流事件的准确性，简化了监测过程。它的可操作性也很高。本研究为临床试验提供了重要的临床前经验。
期刊介绍：
Gastroenterology Report is an international fully open access (OA) online only journal, covering all areas related to gastrointestinal sciences, including studies of the alimentary tract, liver, biliary, pancreas, enteral nutrition and related fields. The journal aims to publish high quality research articles on both basic and clinical gastroenterology, authoritative reviews that bring together new advances in the field, as well as commentaries and highlight pieces that provide expert analysis of topical issues.
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