Routine Versus Symptomatic Protein Pump Inhibitor Therapy for Prevention of Gastroesophageal Reflux After Per Oral Endoscopic Myotomy for Esophageal Achalasia. Randomized Open-label Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 132
- 试验地点
- 4
- 主要终点
- Presence of pathological acid reflux between groups
研究概览
简要总结
Per Oral Endoscopic Myotomy (POEM) is a treatment of choice for achalasia with an excellent safety and efficacy profile. There is a high rate of esophagitis related to gastroesophageal reflux following this procedure. There is no recommendation on the prescription of protein pump inhibitors (PPI) after the procedure and no study has studied the benefit of systematic prescription of PPI after POEM for achalasia. The study authors hypothesize that routine PPI prescribing post-POEM for 12 months would reduce the rate of esophageal acid exposure compared to a symptom-based prescribing strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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 with an indication for esophageal POEM for achalasia
- •Patient with all types of achalasia with Eckardt score > 3
- •The patient must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan
排除标准
- •Patient with contraindications to PPIs
- •Patient with mediastinal and esophageal neoplasia
- •Patient with a history of Heller myotomy surgery
- •Patients requiring any type of anti-reflux valve surgery
- •The subject is in a period of exclusion determined by a previous study
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
- •Patient is pregnant, parturient or breastfeeding
研究组 & 干预措施
Systematic protein pump inhibitor therapy
干预措施: Protein pump inhibitor therapy systematically (Drug)
Protein pump inhibitor therapy as necessary
结局指标
主要结局
Presence of pathological acid reflux between groups
时间窗: Month 6
According to the Lyon 2018 criteria: Esophagitis grade C or D according to the Los Angeles classification and/or acid exposure \>6% on 24-hour esophageal pH-metry
次要结局
- Presence of pathological acid reflux between groups(Month 12)
- Patient quality of life between groups(Month 12)
- Treatment tolerance between groups(Month 12)
- Achalasia symptoms between groups(Month 12)
- Patient health-related quality of life between groups(Month 12)
- Quantity of PPI consumed between groups(Month 12)
- Pyrosis symptoms between groups(Month 12)
- Patient quality of life between groups(Week 6)
- Patient quality of life between groups(Month 6)
- Patient health-related quality of life between groups(Week 6)
- Patient health-related quality of life between groups(Month 6)
- Quantity of PPI consumed between groups(Month 3)
- Quantity of PPI consumed between groups(Month 6)
- Achalasia symptoms between groups(Week 6)
- Achalasia symptoms between groups(Month 6)
- Pyrosis symptoms between groups(Month 6)
- Patient quality of life between groups(Inclusion)
- Patient health-related quality of life between groups(Inclusion)