Endoscopic Treatment of Gastroesophageal Reflux Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change from baseline esophageal 24 hour pH/impedance at 3 months
研究概览
简要总结
Gastroesophageal reflux disease (GERD) occurs when stomach acid repeatedly flows back into the tube connecting your mouth and stomach (esophagus). This backwash (acid reflux) can irritate the inner lining of the esophagus. This is a particular problem after surgery to reduce obesity called gastric sleeve resection.
The goal of this small clinical trial is to examine the effect of endoscopic treatment of GERD by mucosal band ligation. The main questions it aims to answer are:
- Does the treatment affect gastroesophageal reflux assessed by measuring gastroesophageal reflux
- Does the treatment affect gastroesophageal reflux symptoms and ability to stop treatment with medication commonly used (proton pump inhibitors)
Participants (n=12) will be asked to undergo 24 h reflux examination and report symptoms of GERD. Suitable patients will be offered endoscopic treatment with band ligation of the inner lining of the lower esophagus and upper part of the stomach. The effects will be assessed three and six months after the procedure.
详细描述
Gastroesophageal reflux disease (GERD) is very common after gastric sleeve resection and many patients are dependent on daily use of proton pump inhibitors (PPIs). The goal of this small clinical trial is to examine the effect of endoscopic treatment of GERD by mucosal band ligation.
Patients (n=12) with GERD satisfying inclusion and exclusion criteria will be invited to participate and the degree of gastroesophageal reflux will be assessed before treatment, and three and six months after the procedure. The results of the trial will be used to plan a larger study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •(all criteria must be fulfilled):
- •Previous gastric sleeve resection
- •GERD. GERD must be diagnosed by either endoscopic esophagitis or esophageal pH measurement with DeMeester score > 14.72 and pH <4 more than 4% of a 24-h period and symptom association probability (SAP) > 95%
- •Subjective insufficient symptom control with PPI therapy once daily or intolerance to PPI or desire to stop PPI treatment and therefore willingness to undergo endoscopic treatment.
排除标准
- •Hiatal hernia > 5 cm
- •Age < 18_years
- •Preexisting esophageal stricture
- •Gastric stricture < 2 cm in diameter
- •Anti-coagulant medication
- •Use of platelet inhibitors other than acetylsalicylic acid
- •Manometric indication of motility disorder
- •Connective tissue diseases
- •BMI > 35
- •Liver cirrhosis
- •Coronary heart disease
- •Chronic obstructive pulmonary disease
- •Other significant comorbidity
- •Indication for long-term PPI use other than GERD
结局指标
主要结局
Change from baseline esophageal 24 hour pH/impedance at 3 months
时间窗: 3 months
Esophageal pH/impedance will be measured by a catheter left in place for 24 hours
Adverse events during the study period of 6 months
时间窗: 6 months
Adverse events or complications of the treatment will be registered during the study period
Change from baseline symptoms of gastroesophageal reflux at 3 months
时间窗: 3 months
GERD Q score. Gastroesophageal reflux disease Questionnaire with minimum value 0 (no symptoms) and maximum value 18 (severe symptoms)
Change from baseline in use of proton pump inhibitors (PPI) at 3 months
时间窗: 3 months
PPI use (number of days PPI was used during the period 7-14 days before the 3 months visit)
Change from baseline esophageal 24 hour pH/impedance at 6 months
时间窗: 6 months
Esophageal pH/impedance will be measured by a catheter left in place for 24 hours
Change from baseline symptoms of gastroesophageal reflux at 6 months
时间窗: 6 months
GERD Q score. Gastroesophageal reflux disease Questionnaire with minimum value 0 (no symptoms) and maximum value 18 (severe symptoms)
Change from baseline in use of proton pump inhibitors (PPI) at 6 months
时间窗: 6 months
PPI use (number of days PPI was used during the period 7-14 days before the 6 months visit)
次要结局
- Change from baseline in Hills flap valve at 3 months(3 months)
- Change from baseline in dysphagia at 3 months(3 months)
- Change from baseline in dysphagia at 6 months(6 months)
- Change from baseline in Hills flap valve at 6 months(6 months)