Role of Mucosal Impedance Measurement for the Diagnosis of Gastroesophageal Reflux Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- diagnostic performance
研究概览
简要总结
Existing current tests for diagnosing GERD are suboptimal because they lack adequate sensitivity or specificity. Upper gastrointestinal endoscopy is highly specific for diagnosing GERD, particularly when erosive esophagitis is present (Los Angeles Classification B, C, or D). Nevertheless, its sensitivity is limited, as this scenario is only present in 30% of cases. Most patients will exhibit normal endoscopic findings, indicating Non-Erosive Reflux Disease (NERD). The 24-hour impedance-pH monitoring (MII) is currently considered the gold standard. However, its main limitation is that it can only measure reflux activity over a 24-hour period, in addition to the discomfort caused by the catheter. 6-8 It is noteworthy that 50% of patients with NERD will have pathological reflux, and the other 50% will have a sensory disorder. The importance of making an accurate diagnosis lies in the treatment, which varies in each case.11 Recently, a minimally invasive device was developed and validated in the USA to assess changes in esophageal mucosal impedance. This serves as a tool for evaluating tissue changes associated with chronic reflux. However, this device has recently undergone improvements. This new technology has not been tested yet for GERD diagnosis. The primary benefit would be the ability to diagnose GERD in symptomatic patients with NERD during the initial endoscopy conducted under sedation.
Objectives
The Main objectives of this study are to:
- Evaluate the diagnostic performance of mucosal impedance measurement.
- Investigate the mucosal impedance pattern in patients with and without GERD.
Secondary objectives:
- Evaluate the correlation between the global mucosal impedance measurement vs the first 3cm measurement
- Evaluate the best probability score to distinguish between GERD and non-GERD Design Prospective, cross-sectional, and analytical study Study Design and Procedures The study will be conducted in the Gastroenterology Department of the Hospital de Clínicas José de San Martin, University of Buenos Aires, Argentina. Following a 4-week screening period during which a proton pump inhibitor (PPI) washout will be performed, and baseline measurements will be taken, all patients will undergo upper gastrointestinal endoscopy with mucosal impedance measurement and 24-hour impedance/pH monitoring.
详细描述
Gastroesophageal Reflux Disease (GERD) occurs when gastroduodenal content refluxes, causing bothersome symptoms and/or complications. 1 It is estimated that GERD affects 20-30% of the population in Western countries 2 (23% in Argentina), and it is associated with an impairment in the quality of life and significant healthcare costs. 3-5 Existing current tests for diagnosing GERD are suboptimal because they lack adequate sensitivity or specificity. Upper gastrointestinal endoscopy is highly specific for diagnosing GERD, particularly when erosive esophagitis is present (Los Angeles Classification B, C, or D). Nevertheless, its sensitivity is limited, as this scenario is only present in 30% of cases. Most patients will exhibit normal endoscopic findings, indicating Non-Erosive Reflux Disease (NERD). The 24-hour impedance-pH monitoring (MII) is currently considered the gold standard. However, its main limitation is that it can only measure reflux activity over a 24-hour period, in addition to the discomfort caused by the catheter. 6-8 The last Lyon Consensus considered GERD when erosive esophagitis is present (Los Angeles Classification B, C, or D) or acid exposure time (AET) is >6% on ambulatory studies. Acid exposure time <4% definitively rules out pathologic gastroesophageal acid reflux, while AET between 4-6% is considered borderline. 9,10 It is noteworthy that 50% of patients with NERD will have pathological reflux, and the other 50% will have a sensory disorder. The importance of making an accurate diagnosis lies in the treatment, which varies in each case.11 Recently, a minimally invasive device was developed and validated in the USA to assess changes in esophageal mucosal impedance. This serves as a tool for evaluating tissue changes associated with chronic reflux.12 However, this device has recently undergone improvements. This new technology has not been tested yet for GERD diagnosis. The primary benefit would be the ability to diagnose GERD in symptomatic patients with NERD during the initial endoscopy conducted under sedation.
Objectives
The Main objectives of this study are to:
- Evaluate the diagnostic performance of mucosal impedance measurement.
- Investigate the mucosal impedance pattern in patients with and without GERD.
Secondary objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >18 years presenting symptoms of GERD that have not adequately responded to proton pump inhibitors (PPIs) treatment after 8 weeks and have undergone upper gastrointestinal endoscopy (UGIE) without erosive esophagitis.
- •Patients with a broad spectrum of severity, assessed through the GERDq score, will be included
排除标准
- •● Pregnancy or lactation
- •Esophageal disorders (esophageal motor disorders, eosinophilic esophagitis, neoplastic diseases)
- •Uncontrolled systemic diseases (diabetes mellitus, hypo- or hyperthyroidism, cancer, etc.)
- •Lack of informed consent
- •Severe psychiatric disorders
结局指标
主要结局
diagnostic performance
时间窗: immediately after the intervention/procedure
diagnostic performance of mucosal impedance measurement
mucosal impedance pattern
时间窗: immediately after the intervention/procedure
mucosal impedance pattern in patients with and without GERD.
次要结局
- Probability score(immediately after the intervention/procedure)
- Correlations(immediately after the intervention/procedure)
研究者
Maria Marta Piskorz
Principal Investigator
Hospital de Clinicas José de San Martín