Double-blind, Placebo-controlled Clinical Trial on the Efficacy of Antireflux Ablation of the Cardiac Mucosa for the Treatment of Gastroesophageal Reflux Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 9
- 主要终点
- To evaluate the clinical efficacy (measured through the GERD-HRQL questionnaire) of the ARMA technique for the endoscopic treatment of PPI-dependent GERD.
研究概览
简要总结
Gastroesophageal reflux disease (GERD) is defined as the presence of symptoms or complications secondary to the passage of gastric contents into the esophagus, oral cavity or structures of the airway. The prevalence worldwide is between 8-33%. The clinical practice guidelines of the American College of Gastroenterology establish that first-line treatment, in the absence of alarm symptoms, should be carried out empirically. This treatment consists of hygienic-dietary measures and the use of proton pump inhibitors (PPIs) for 8-12 weeks. Despite the proven effectiveness of PPIs, there is 10-40% of patients who do not respond adequately to this treatment. All this has motivated the appearance of endoscopic and surgical techniques that offer an alternative to medical treatment. Among them is the technique of antireflux ablation of the cardiac mucosa (ARMA) in which the resection of the mucosa is replaced by an ablation with electrocoagulation current or by argon gas fulguration.
详细描述
Gastroesophageal reflux disease (GERD) is defined as the presence of symptoms or complications secondary to the passage of gastric contents into the esophagus, oral cavity or structures of the airway. The prevalence worldwide is between 8-33%. The clinical practice guidelines of the American College of Gastroenterology establish that first-line treatment, in the absence of alarm symptoms, should be carried out empirically. This treatment consists of hygienic-dietary measures and the use of proton pump inhibitors (PPIs) for 8-12 weeks. Despite the proven effectiveness of PPIs, there is 10-40% of patients who do not respond adequately to this treatment. All this has motivated the appearance of endoscopic and surgical techniques that offer an alternative to medical treatment. Among them is the technique of antireflux ablation of the cardiac mucosa (ARMA) in which the resection of the mucosa is replaced by an ablation with electrocoagulation current or by argon gas fulguration.
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
- Double (Participant, Investigator)
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
- •Age over 18 years.
- •GERD symptoms lasting more than 6 months, not necessarily consecutive. They should at least have a typical GERD symptom (heartburn or regurgitation).
- •Total acid exposure time> 6% in pH measurement study without PPI treatment.
- •Patients who do not want to take PPIs or with chronic consumption, defined as PPI consumption of more than 6 months (consecutive or not) in the last 2 years.
- •Response to PPI treatment, defined as an increase of> 10 points on the GERD-HRQL questionnaire 15 days after discontinuation of the PPI.
- •Written informed consent to participate in the study.
排除标准
- •Patients with sliding hiatal hernia> 2 cm.
- •Presence of only atypical GERD symptoms.
- •Age> 75 years.
- •Grade D peptic esophagitis.
- •Body mass index> 35 40 kg / m
- •Liver cirrhosis.
- •Incomplete relaxation of the LES in MAR (PIR> 15 mmHg).
- •Absent peristalsis, defined as 100% failed waves with DCI <100 mmHg * cm * s in MAR.
- •Esophagogastric surgery or previous endoscopic antireflux technique.
- •Barrett's esophagus with dysplasia.
- •Oncological disease.
- •Esophageal strictures or ulcers.
- •Severe cardiopulmonary comorbidity (ASA functional class IV-V).
- •Previously known coagulopathy.
- •Severe psychiatric disorder
- •Refusal to participate in the study.
结局指标
主要结局
To evaluate the clinical efficacy (measured through the GERD-HRQL questionnaire) of the ARMA technique for the endoscopic treatment of PPI-dependent GERD.
时间窗: The GERD-HRQL questionnaire score without PPI from visit 1 will be compared with the score without PPI from visit 4 (month 12).
GERD-HRQL questionnaire score. Quantitative variable. Clinical success will be defined as a\> 50% reduction in symptom score. The scale has 11 items. Each item is scored from 0 to 5, with a higher score indicating a better QOL.
次要结局
- GERD-Q questionnaire score(The GERD-Q questionnaire score without PPI from visit 1 will be compared with the score without PPI from visit 4 (month 12).)
- PPI consumption(It is measured in the different visits after the intervention (month 1, month 3 and month 12))
- pHmetry-impedancemetry(This test will be performed on the patient before the intervention, in month 3 and in month 12)
- High resolution manometry(This test will be performed on the patient before the intervention, in month 3 and in month 12)