Impact of Peroral Endoscopic Myotomy and Other Treatments for Oesophageal Motility Disorders on Bolus Transport and Gastro-oesophageal Reflux. The pFlow Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Bolus Pressure and Flow (PF) modification
研究概览
简要总结
Pressure and flow (PF) analysis allow a detailed report on the bolus passing for each segment of the esophagus. This approach has evidence in oropharyngeal dysphagia, post reflux surgery dysphagia, gastroesophageal reflux in infants and dysphagia in patients with normal manometry. However, it has not been used for defined esophageal motility disorders and their response to surgical or endoscopic treatments. Better knowledge about pre and postoperative bolus flow can yield important concepts that can modify the selection of optimal treatments.
详细描述
Methods This is an international multicenter prospective observational study in a cohort of individuals affected by an oesophageal motor disorder (OMD).
Participating centers OMD are treated in most tertiary hospitals surgically (Laparoscopic Heller Myotomy (LHM)) or endoscopically (botulinic toxin injection, pneumatic dilatation or peroral endoscopic myotomy (POEM)). The main requirement is to perform high-resolution manometry with impedance before and after the procedure.
Subjects Inclusion criteria are to present with gastrointestinal (GI) symptoms that are secondary to OMD such as dysphagia, regurgitation and/or non-cardiac chest pain. OMD under study are achalasia type I, II and III; oesophagogastric junction (OGJ) outflow obstruction; distal oesophageal spasm, hypercontractile oesophagus or disorders not fulfilling Chicago Criteria version 3. Treatments included are outlined in the previous paragraph.
Exclusion criteria are the inability to fill in symptom questionnaires, intolerance of pre or postprocedure test, incomplete therapeutic procedures or artifacts in manometry/impedance tracings.
Data sharing High-resolution manometry (HRM)-impedance studies will be shared and PF analysis will be performed through Swallow Gateway®. See Appendix 1 for further detail. An acrobat sheet will be eased to fill-in symptomatic and test data pre and post-procedure. It will also be shared through Swallowgateway®.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •to present with GI symptoms that are secondary to EMD such as dysphagia, regurgitation and/or non-cardiac chest pain.
- •the EMD patients to be recruited under this study are achalasia type I, II and III; OGJ outflow obstruction; distal oesophageal spasm, hypercontractile oesophagus or disorders not fulfilling Chicago Criteria v
- •Receive a treatment such as POEM, neumatic dilatation, LHM, botox injection.
排除标准
- •Exclusion criteria are the inability to fill in symptom questionnaires, intolerance of pre or post procedure test, incomplete therapeutic procedures or technical failure of baseline manometry investigation
结局指标
主要结局
Bolus Pressure and Flow (PF) modification
时间窗: 6 months
Compare oesophageal biomechanics (based on PF analysis) before and after the different surgical or endoscopic treatments for oesophageal motility disorders (OMD). This analysis describes through numeric variables the passing of the bolus from the mouth to the stomach regarding resistance of flow, clearance and velocity for every part of the oesophagus
次要结局
- PF analysis within similar OMD(6 months)
- Symptom correlation(12 months)
- Clinical success correlation(12 months)
- Correlation with barium column(6 months)
- Correlation with reflux(6 months)