Efficacy and Safety of Endoscopic Anti-reflux Mucosal Ablation Therapy for Gastroesophageal Reflux Disease: a Single Blind Randomized Sham Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 68
- 主要终点
- Improvement of gastroesophageal reflux disease symptoms
研究概览
简要总结
The goal of this randomized clinical trial is to investigate the efficacy and safety of antireflux mucosal ablation (ARMA) for patients with refractory gastroesophageal reflux disease (GERD). The trial aim to evaluate :
- Efficacy of ARMA comparing with medical treatment alone (proton pump inhibitor (PPI)), using GERD-Health Related Quality of Life Questionnaire (GERD- HRQL questionnaire), improvement of acid exposure time and DeMeester score
- Safety and complications of ARMA Participants will be randomly divided into 2 groups. The intervention group will be undergone ARMA, and the control group will be undergone sham endoscopic treatment.
The primary endpoint will be symptoms relief (GERD-HRQL decreases > 50%). The secondary endpoint will be dosage adjustment of PPI, complications, improvement of acid exposure time and DeMeester score.
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, Care Provider)
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
- •Adults aged over 18 years old
- •History of GERD for over 6 months, who had received PPIs for over 6 months but still had symptoms of typical GERD symptoms (GERD-HRQL score of >8, acid reflux sensation or heartburn), and/or other symptoms as lump throat, night cough, acid related chest tightness (without other possible explanation of these symptoms)
- •Acid exposure time > 6%
- •DeMeester score ≥ 14.72
排除标准
- •Pregnancy
- •Hiatal hernia > 2cm or Flap Valve Hill grade III/IV
- •GERD LA grade C/D or esophageal ulcer
- •Abnormal anatomy of esophagus (esophagectomy, stricture, diverticulum)
- •Barrett's esophagus with dysplasia
- •Esophageal motility disorders
- •History of gastroparesis
- •Cirrhosis
- •Esophageal and gastric varices
- •Previous gastric surgery and anti-reflux procedures
- •History of scleroderma or dermatomyositis
- •Coagulation disorders (Bleeding tendency and coagulopathy)
- •History of oncological disease (not active within 2 years)
研究组 & 干预措施
Antireflux mucosal ablation
In patients fulfilling the inclusion criteria and being randomized for ARMA, retroflexion endoscopy to visualize the cardia is performed, followed by mucosa markings with straight-fire APC catheter (ERBE Electromedizin, Tübingen, Germany) in forced coagulation mode (VIO300D, ERBE Electromedizin, Tübingen, Germany, 20W). The marking site at 1-cm and 2-cm distal to squamocolumnar junction at anterior-posterior and lesser curvature site, respectively, sparing the greater curvature site of cardia, is done. After marking, mucosal ablation (forced coagulation mode, 1L/min, 80W) is performed at marking site in a hoarse-shoe shape. Adequate ablation depth is defined as reaching the submucosal layer with blackish discolored tissue with carbonization
干预措施: Antireflux mucosal ablation (Procedure)
Sham procedure
In patients fulfilling the inclusion criteria and being randomized for sham procedure, retroflexion endoscopy to visualize the cardia is performed. Using the straight-fire APC catheter to touch the marking sites similar to the treatment group without electrocauterization is performed
干预措施: Sham procedure (Procedure)
结局指标
主要结局
Improvement of gastroesophageal reflux disease symptoms
时间窗: 3 months
Clinical success is defined as more than 50% improvement of the GERD-HRQL questionnaire at 3 months after the ARMA procedure. The results are from minimal 0 points up to 50 points. The higher the points, the greater the symptoms.
次要结局
- Complication rate(12 months)
- PPI dependency(12 months)
- Changes in DeMeester score(12 months)
- Changes in acid exposure time(12 months)
- Changes in lower esophageal sphincter pressure(12 months)