Comparative Assessment of Reflux Esophagitis in Cases With and Without Esophageal Motility Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- comparison of reflux esophagitis in cases who undergo POEM procedure versus those without esophageal motility disorders
研究概览
简要总结
Achalasia is a neuro-degenerative disorder marked by changes in the peristalsis of the esophagus and the lack of relaxation in the lower esophageal sphincter (LES), thought to be due to damage to the myenteric plexus with an unknown cause.1 Per-oral endoscopic myotomy (POEM) is an established endoscopic treatment modality for achalasia. Leading gastrointestinal (GI) societies endorse POEM as one of the primary treatment option for achalasia.This study aims to characterize and compare the morphological characteristics of reflux related erosions after the POEM procedures versus those in cases without esophageal motility disorders.
Data collection
- Demographic characteristics: Age, gender, type of achalasia
- Manometry findings (pre and post POEM): integrated relaxation pressure, lower esophageal sphincter pressure
- Comorbidities
- Medications
- Eckardt score: before procedure and 3-months after Procedure
- POEM procedure details: length of esophageal and gastric myotomy, adverse events, length of hospital stay
- Evaluation at 3-months Symptom: standardized questionnaire (GERDQ) Endoscopy: grade of esophagitis Erosions vs ulcers Dimension of erosions Anatomical location (according to clock)
详细描述
POEM will be performed using a standardized technique.8 The patients will be prescribed a single dose anti-secretory medicine (equivalent to 40 mg esomeprazole) for two months after POEM. Consecutive patients who meet the inclusion and exclusion criteria will be followed up after 3 months. PPIs will be discontinued for at least 4 weeks prior to objective evaluation of GERD. Each patient returning after 3 months for follow up will undergo several follow up examinations, including GERD questionnaire scoring, Esophagogastroduodenoscopy, 24 hour pH impedance test. Presence of endoscopically visible esophagitis . Endoscopic findings such as anatomical location, dimensions of the mucosal breaks will be compared to general population with diagnosis of GERD who have endoscopically visible esophagitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed diagnosis of Achalasia,
- •No contraindication to POEM,
- •erosive esophagitis on endoscopy
排除标准
- •Non-esophageal esophageal motility disorders,
- •Treatment other than POEM,
- •current PPI use before assessment for GERD
研究组 & 干预措施
Assesment of reflux esophagitis in cases with esophageal motility
Reflux esophagitis can be found in Endoscopy report.
干预措施: Per oral endoscopy myotomy (Per oral endoscopy myotomy) (Procedure)
Assesment of reflux esophagitis in cases without esophageal motility
Reflux esophagitis can be found in cases in normal gastroesophageal reflux disease condition patients
干预措施: Endoscopy procedure (Procedure)
结局指标
主要结局
comparison of reflux esophagitis in cases who undergo POEM procedure versus those without esophageal motility disorders
时间窗: 3 months
Reflux esophagitis can be calculated as grade B category (red colour scar found in esophagus mucosa) during endoscopy procedure
Assessment of the , esophageal acid exposure
时间窗: 6 months
esophageal acid exposure is a value indicates higher reflux can be calculated in ph impedence report
次要结局
未报告次要终点
研究者
Mohan Ramchandani
Director
Asian Institute of Gastroenterology, India