Diagnostic Yield of Post PRandial Esophageal High Resolution Impedance Manometry in Patients With Gastro-Esophageal Reflux Disease Symptoms Resistant to Proton Pump Inhibitor Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 330
- 试验地点
- 14
- 主要终点
- Number of reflux episodes identified on the post prandial HRIM
研究概览
简要总结
Gastro-esophageal reflux disease (GERD) is defined as the reflux of gastric content into the esophagus that causes troublesome symptoms or complications. Nine to 30% of the population suffers from GERD-suggestive symptoms (heartburn, regurgitation, chest pain, chronic couch, sore throat). In the absence of warning signs, proton pump inhibitors (PPI) are prescribed as first-line treatment. However, 20 to 60% of patients are unsatisfied because of persistent symptoms when taking PPI. Causes of persistent symptoms are: erroneous diagnosis of GERD (up to 50% of PPI non-responders), rumination syndrome, excessive weakly acid reflux on PPI due to defective esophago-gastric junction or an excessive number of transient lower esophageal sphincter relaxations (main mechanism of GERD), poor acid secretion inhibition on PPI, and non-compliance to therapy. Complementary examinations are indicated to explain persistent GERD symptoms. Upper gastro-intestinal endoscopy is performed first to rule out an esophageal tumor and to identify erosive esophagitis, a specific sign of GERD. However, it is normal in up to 70% of symptomatic GERD patients. Direct detection of reflux episodes is then requested to confirm GERD. The gold standard for reflux detection is the ambulatory measurement of esophageal pH for 24 to 96 hours using a catheter (catheter-based pH-monitoring) or a capsule clipped into the esophagus (wireless pH-monitoring). Reflux episodes are defined as an esophageal pH < 4. Another method of reflux detection is based on liquid and gas detection in the esophagus using pH-impedance monitoring. Recently the combination of impedance and esophageal pressure monitoring, called esophageal high resolution impedance manometry (HRIM) was introduced to simultaneously identify reflux episodes and their mechanisms. It has several advantages over esophageal pH measurement: shorter recording duration (1 or 2 hours post prandial) and identification of reflux mechanisms that might guide the choice of the best therapeutic option.
Hypothesis: The 1-hour post prandial esophageal HRIM might be useful to diagnose GERD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient older than 18 years
- •Typical symptoms of GERD (heartburn, regurgitation) at least twice a week despite PPI therapy for at least one month.
- •Reflux Disease Questionnaire (RDQ) score off PPI > 3
- •Subject with health insurance
排除标准
- •Previous esophago-gastric surgery,
- •Previous history of developing esophageal or gastric tumor, esophageal stricture, or esophageal varices
- •Pregnancy (assessment at V0)
- •Contraindication to general anesthesia,
- •Contraindications to the wireless capsule pH-monitoring: pacemakers, implantable cardiac defibrillator,
- •Contraindications to HRIM: inability to tolerate nasal intubation, significant bleeding disorders for which nasal intubation is contraindicated, known esophageal obstruction is preventing the passage of the HRIM probe.
- •Intolerance or allergy to one component of the test meal,
- •Intolerance or allergy to PPI,
- •Inability to give consent,
- •Mentally unbalanced patients, under supervision or guardianship
- •Decline to participate in the study,
- •Participation in another study at the same time
结局指标
主要结局
Number of reflux episodes identified on the post prandial HRIM
时间窗: 1 hour after the end of the meal
The diagnostic performance of the number of reflux episodes measured by 1-hour post prandial HRIM will be evaluated by estimating the Area Under the ROC Curve and its 95% confidence interval. The gold standard to define GERD will be based on esophageal pH measurements with capsule (GERD is defined as acid exposure time (AET; percentage of total time with esophageal pH \< 4) greater than 6% for at least one day on wireless pH monitoring).
次要结局
- Baseline impedance measured on post prandial HRIM(1 hour after the end of the meal)
- Resting pressure of the esophago-gastric junction(1 hour)
- Response to 4-week regimen of dose PPI(4 weeks)
- Reflux mechanisms defined on post prandial HRIM(1 hour after the end of the meal)
- Esophageal histology(4 weeks)
- Normalization of the number of reflux episodes detected on 24-h pH-impedance monitoring performed on PPI(1 day)
- Patient's preference regarding the type of examination(1 day)
- Acid exposure time measured on wireless pH-monitoring(4 days)
- Normalization of the acid exposure time measured on 24-h pH-impedance monitoring performed on PPI(1 day)