Prospective Evaluation of PH-impedance Tracings According to the Wingate Consensus, and Influence on Gastro-oesophageal Reflux Disease (GERD) Classification According to the Lyon Consensus.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Statistical difference in the GERD categorisation
研究概览
简要总结
Commonly, in clinical practice an automated analysis of pH-MII tracings is obtained.
详细描述
All pH-MII performed in UZ Brussel are already reviewed manually according to the Wingate con-sensus and interpreted according to the Lyon consensus. In this study, we will prospectively categorise the reasons for discarding reflux episodes identified by automated analysis during the manual review according to the Wingate consensus, as well as the impact on different parameters related to the interpretation of pH-MII. Based on comments received to our retrospective study, we will evaluate possible confounders to the interpretation, including the indication for referral for pH-MII, symptom severity, use of PPI during pH-MII.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 - 80 years old;
- •pH-MII performed off PPI
排除标准
- •Prior upper GI endoscopy indicative of structural disease (except for oesophagitis or hiatal hernia).
- •Incomplete pH-MII (less than 21 hours recording);
- •Ph-MII performed on PPI
- •Suboptimal quality of the tracings preventing interpretation in clinical practice;
- •Prior oesophageal (including anti-reflux intervention) or gastric surgery.
结局指标
主要结局
Statistical difference in the GERD categorisation
时间窗: During baseline visit
the statistical difference in the distribution of GERD categorisation between automated vs. manual review of the pH-MII tracings
次要结局
- The analysis of the influence of different parameters on application of the Wingate criteria: including MNBI (obtained by automated analysis or manually calculated);(During baseline visit)
- Presence of significant correlations between censored episodes and pH-MII parameters(During baseline visit)
- The analysis of the influence of different parameters on application of the Wingate criteria: including the GERD Symptom Severity;(During baseline visit)
- The analysis of the influence of different parameters on application of the Wingate criteria: including the Indication for referral with further classification into predominant oesophageal and extra-oesophageal symptoms;(During baseline visit)
- Impact of the Wingate criteria on The number of PSPW;(During baseline visit)
- Impact of the Wingate criteria on The number of symptoms associated with an impedance episode.(During baseline visit)
- Impact of the Wingate criteria on the number of impedance episodes with or without acidic reflux(During baseline visit)
- The analysis of the influence of different parameters on application of the Wingate criteria: including the patient being on or off PPI;(During baseline visit)