Comparison of Anti-Reflux Mucosal Ablation(ARMA) With Anti- Reflux Mucosectomy(ARMS) in Treatment of Gastroesophageal Reflux Disease- A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Reflux synptom improvement after different treatment.
研究概览
简要总结
According to the current published data and treatment mechanism, ARMS may led to more stenosis while ARMA may be less effective in long term follow-up. The changes of patient's life quality , UGI tract microbiota before and after different endoscopic treatment are also limited. So we want to conduct a exploratory prospective randomized controlled study in evaluating the mucosal healing, demand of PPI, life quality, emotion status, sleep quality, esophageal motility/ acid exposure and saliva microbiota between chronic GERD patients receiving ARMS and ARMA treatment.
详细描述
In this study, we will enroll 150 patients with chronic GERD. Estimated 40% of patients will be excluded from the inclusion and exclusion criteria. Of 90 patients eligible for the study, estimating 20% may drop out before receiving ARMS or ARMA. Estimated 72 patients will be randomized to receive ARMS or ARMA for GERD treatment. After ARMA, all patients will receive 4 weeks of PPI treatment. Endoscopy and questionnaire follow-up will be performed on week 2, 2 months, 6 months and 12 months after treatment while HRM and 24 hours pH impedance study will be performed 6 months after treatment.
The study will be carried out in 4 years. In the 1st to 3rd year of study, estimating 60,60,30 patients will be evaluated and entered the study in the 1st, 2nd and fisr half of 3rd year. Then all the patients will be followed until the first half of 4th year. At the second half of the 4th year, the saliva sample will be processed, data will be analyzed, and the result will be written.
- st year study:60 patients enrollment, evluation and receiving endoscopy treatment with follow-up
- nd year study:60 patients enrollment, evluation and receiving endoscopy treatment with follow-up
- rd year study:30 patients enrollment, evluation and receiving endoscopy treatment with follow-up
- th year study: complete all patients follow-up, sample processing, data analysis and report writing
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 (Participant)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20-75 years of age,
- •History of GERD over 1 year
排除标准
- •body mass index (BMI) > 35
- •Hiatal hernia > 2cm
- •Esophageal ulcer
- •Esophageal stricture
- •Barrett's esophagus (Prague criteria: C>1cm, M>=2cm)
- •Major esophageal motility disorders
- •Gastroparesis
- •Pregnancy or plans for pregnancy in the next 12 months
- •Immunosuppressive therapy
- •Cirrhosis
- •Portal hypertension and/or varices
- •Previous gastric or esophageal surgery
- •Esophageal diverticulum
- •Scleroderma or dermatomyositis
- •Coagulation disorders
- •Anti-platelet or anticoagulants use
结局指标
主要结局
Reflux synptom improvement after different treatment.
时间窗: 6 months
Reflux synptom improvement in 6 months after ARMS and ARMA. Complete remission group will be defined as GERD-Q score of \<8 and discontinuing PPI medication. Patients with post- ARMS GERD-Q score of \<8 and reduced PPI medication will be allocated to the partial response group. Others will be defined as non-response group.
次要结局
- change of saliva microbiota(2 months)
- Comparisons of GERD DeMeester scores(12 months)
- Comparisons of GERD acid exposure time(12 months)
- improvement of GERD-Health Related Quality of Life Questionnaire (GERD-HRQL)(6 months)