Anti Reflux Mucosal Ablation Therapy in PPI Dependent GERD: a Prospective Randomized, Single-blinded, Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Improvement in symptoms of gastro esophageal reflux disease
研究概览
简要总结
This is a prospective, randomized, single-blinded, interventional, controlled trial to evaluate the efficacy and safety of endoscopic anti reflux mucosal ablation (ARMA) in PPI dependent gastroesophageal reflux disease (GERD) in comparison to controls with a sham procedure.
详细描述
Patients who fulfill the inclusion criteria and, after informed consent, are willing to participate in this study will be prepared for ARMA. After sedation the patients will be randomized equally into an intervention and control Group. The patients are blinded to the procedure. The Patients in the intervention group receive ARMA using argon plasma coagulation (APC) at the gastroesophageal junction (EGJ) in two semicircular patterns while the control group receives a sham procedure. The approximate duration of the procedure is 30min. After the procedure the patients receive follow up controls at 2, 4, 6 and 12 months. During the first follow up, 2 months after the procedure symptoms are evaluated by questionnaires (GERD- HRQL, FSSG, VAG). Subsequently the PPI- medication is stopped in all patients until the end of the study or worsening of symptoms. During the second follow up 4 months after the initial procedure the symptoms are reevaluated by questionnaires. The patients are then unblinded and are told if they received ARMA or sham procedure. Those patients who received ARMA are examined by esophagogastroduodenoscopy, esophageal manometry and pH metry. Further assessments is performed by questionnaires 6 and 12 months after the initial procedure.
Those patients in the control group are allowed to take part in a crossover to receive the ARMA procedure as well. If they receive ARMA, symptoms are reevaluated 2 months after the procedure by questionnaires, esophagogastroduodenoscopy, esophageal manometry and pH metry. Further controls are performed after 4, 6 and 12 months by questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Patients are randomized equally into an intervention and control group. The patients remain blinded to the procedure until 4 months after the initial procedure.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PPI dependent GERD for at least 6 months
- •Pathological esophageal acid exposure, defined by DeMeester score >14.7 or acid exposure time (AET) >4.2% in pH metry while off PPI
- •Exclusion of primary esophageal motility disorders by manometry
- •Upper endoscopy with biopsy (Exclusion of eosinophilic esophagitis)
排除标准
- •Sliding hiatal hernia >3cm
- •Los Angeles grade C/D esophagitis
- •Primary esophageal motility disorders
- •Grade IV Hill´s flap valve
- •Pregnancy or planed pregnancy in the next 12 months
- •Eosinophilic esophagitis
- •Paraesophageal hernia
- •Previous esophageal or gastric surgery
- •Barretts esophagus
- •Liver cirrhosis
- •Lack of consent
- •ASA physical status >III
结局指标
主要结局
Improvement in symptoms of gastro esophageal reflux disease
时间窗: 4 months
Improvement in symptoms of gastro esophageal reflux disease by more than 50% from baseline in GERD-Health Related Quality of Life Questionnaire (GERD- HRQL) at 4 months after procedure. Total score 0-50; higher scores indicate greater complaints.
次要结局
- PPI dependency(12 months)
- Change in esophageal acid exposure at 4 months after ARMA(4 months after ARMA)
- Changes in cardia morphology(4 months after ARMA)
- Technical success rate(1 day)
- Change in lower esophageal sphincter pressure 4 months after ARMA(4 months after ARMA)
- Postinterventional pain(1day)
- Complication rate(12 months)
- Change in symptoms of gastro esophageal reflux disease(12 months)
研究者
Mohamed Abdelhafez
Principal Investigator Dr. Abdelhafez
Technical University of Munich