Digestive Endoscopy Unit, Catholic University, Rome, Italy.
Gastroenterology Unit, Nuovo Regina Margherita Hospital, Rome, Italy.
United European Gastroenterol J. 2016 Jun;4(3):339-42. doi: 10.1177/2050640615610021. Epub 2015 Oct 13.
EndoFaster is novel device able to perform real-time ammonium measurement in gastric juice allowing H. pylori diagnosis during endoscopy. This large study aimed to validate the accuracy of EndoFaster for real-time H. pylori detection.
Consecutive patients who underwent upper endoscopy in two centres were prospectively enrolled. During endoscopy, 4 ml of gastric juice were aspirated to perform automatic analysis by EndoFaster within 90 seconds, and H. pylori was considered present (>62 ppm/ml) or absent (≤62 ppm/ml). Accuracy was measured by using histology as gold standard, and (13)C-urea breath test (UBT) in discordant cases. Accuracy, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) were calculated.
Overall, 189 patients were enrolled, but in seven (3.4%) the aspirated gastric juice amount was insufficient to perform the test. The accuracy, sensitivity, specificity, PPV, and NPV were 87.4%, 90.3%, 85.5%, 80.2%, 93.1%, respectively, and 92.6%, 97.1%, 89.7%, 85.9%, 98.0%, respectively, when H. pylori status was reclassified according to the UBT result in discordant cases.
This study found a high accuracy/feasibility of EndoFaster for real-time H. pylori diagnosis. Use of EndoFaster may allow selecting those patients in whom routine gastric biopsies could be avoided.
EndoFaster 是一种新型设备，能够实时测量胃液中的铵含量，从而在胃镜检查期间诊断 H. pylori。本项大型研究旨在验证 EndoFaster 实时检测 H. pylori 的准确性。
连续纳入在两个中心接受上消化道内镜检查的患者。在胃镜检查过程中，抽吸 4ml 胃液，在 90 秒内通过 EndoFaster 进行自动分析，将 H. pylori 定义为存在（>62ppm/ml）或不存在（≤62ppm/ml）。以组织学作为金标准，并在不一致的病例中使用 (13)C-尿素呼气试验（UBT）来衡量准确性。计算准确性、敏感度、特异度、阳性预测值（PPV）、阴性预测值（NPV）。
总共纳入了 189 例患者，但有 7 例（3.4%）抽吸的胃液量不足以进行检测。当根据不一致病例中的 UBT 结果重新分类 H. pylori 状态时，准确性、敏感度、特异度、PPV 和 NPV 分别为 87.4%、90.3%、85.5%、80.2%和 93.1%，92.6%、97.1%、89.7%、85.9%和 98.0%。
本研究发现 EndoFaster 实时检测 H. pylori 的准确性/可行性较高。使用 EndoFaster 可能可以选择那些可以避免常规胃活检的患者。
