Division of Gastroenterology, Hepatology and Nutrition, Vanderbilt University Medical Center, Nashville, Tennessee.
Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee.
Gastroenterology. 2019 May;156(6):1617-1626.e1. doi: 10.1053/j.gastro.2019.01.253. Epub 2019 Jan 31.
BACKGROUND & AIMS: Diagnostic testing for chronic esophageal disorders relies on histopathology analysis of biopsies or uncomfortable transnasal catheters or wireless pH monitoring, which capture abnormal intraluminal refluxate. We therefore developed a balloon mucosal impedance (MI) catheter system that instantly detects changes in esophageal mucosal integrity during endoscopy over a long segment of the esophagus. We performed a prospective study to evaluate the ability of a balloon-incorporated MI catheter to detect and evaluate esophageal disorders, including gastroesophageal reflux disease (GERD) and eosinophilic esophagitis (EoE).
We performed a prospective study of 69 patients undergoing esophagogastroduodenoscopy with or without wireless pH monitoring. Patients were classified as having GERD (erosive esophagitis or abnormal pH; n = 24), EoE (confirmed with pathology analysis of tissues from both distal and proximal esophagus; n = 21), or non-GERD (normal results from esophagogastroduodenoscopy and pH tests; n = 24). Receiver operating characteristic curves and area under the operating characteristic curve (AUC) were used to compare the accuracy of balloon MI in diagnosis. Probabilities of assignment to each group (GERD, non-GERD, or EoE) were estimated using multinomial logistic regression. Association between MI patterns and diagnoses were validated using data from patients seen at 3 separate institutions.
MI pattern along the esophageal axis differed significantly (P < .01) among patients with GERD, EoE, and non-GERD. Patients with non-GERD had higher MI values along all measured segments. The MI pattern for GERD was easily distinguished from that of EoE: in patients with GERD, MI values were low in the distal esophagus and normalized along the proximal esophagus, whereas in patients with EoE, measurements were low in all segments of the esophagus. Intercept and rate of rise of MI value (slope) as distance increased from the squamocolumnar junction identified patients with GERD with an AUC = 0.67, patients with EoE with an AUC = 0.84, and patients with non-GERD with an AUC = 0.83 in the development cohort. One patient had an adverse event (reported mild chest pain after the procedure) and was discharged from the hospital without further events.
We developed a balloon MI catheter system that instantly detects changes in esophageal mucosal integrity during endoscopy and found it to be safe and able to identify patients with GERD, EoE, or non-GERD. We validated our findings in a separate cohort for patients. ClinicalTrials.gov ID NCT03103789.
慢性食管疾病的诊断测试依赖于活检的组织病理学分析或通过经鼻导管或无线 pH 监测来进行，这些方法可以捕获异常的腔内反流物。因此，我们开发了一种球囊黏膜阻抗（MI）导管系统，该系统可在食管的长段内进行内镜检查时即时检测食管黏膜完整性的变化。我们进行了一项前瞻性研究，以评估球囊结合 MI 导管检测和评估食管疾病（包括胃食管反流病（GERD）和嗜酸性食管炎（EoE））的能力。
我们对 69 例行食管胃十二指肠镜检查的患者进行了前瞻性研究，这些患者中有进行无线 pH 监测的，也有不进行监测的。患者被分类为 GERD（糜烂性食管炎或异常 pH 值；n=24）、EoE（远端和近端食管组织病理学分析均证实；n=21）或非 GERD（食管胃十二指肠镜和 pH 检查均正常；n=24）。我们使用接收者操作特征曲线和操作特征曲线下面积（AUC）来比较球囊 MI 在诊断中的准确性。使用多变量逻辑回归来估计每个组（GERD、非 GERD 或 EoE）的分配概率。使用来自 3 家不同机构就诊的患者的数据验证 MI 模式与诊断之间的关系。
GERD、EoE 和非 GERD 患者的食管轴线上的 MI 模式有显著差异（P<0.01）。非 GERD 患者的所有测量段的 MI 值均较高。GERD 的 MI 模式与 EoE 很容易区分：在 GERD 患者中，远端食管的 MI 值较低，而近端食管的 MI 值正常，而在 EoE 患者中，食管所有段的测量值均较低。从鳞柱状交界处到 MI 值增加的距离的截距和 MI 值上升率（斜率）可识别 GERD 患者，AUC 为 0.67，EoE 患者，AUC 为 0.84，非 GERD 患者，AUC 为 0.83，这在开发队列中得到了验证。一名患者发生了不良事件（报告在手术后有轻度胸痛），但出院后没有进一步的事件发生。
我们开发了一种球囊 MI 导管系统，该系统可在进行内镜检查时即时检测食管黏膜完整性的变化，我们发现该系统安全有效，能够识别 GERD、EoE 或非 GERD 患者。我们在另一组患者中验证了我们的发现。临床试验注册号：NCT03103789。
