A Novel Endoloop Pre-test to Treat Gastroesophageal Reflux Before Anti-reflux Surgery or Endoscopic Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in Reflux Symptom Index (RSI) questionnaire scores
研究概览
简要总结
The purpose of this study was to evaluate the safety and efficacy of endoscopic endoloop pre-test for gastroesophageal reflux before anti-reflux surgery or endoscopic treatment. In the study, the investigators used the novel pre-test to narrow the gastric cardia to control symptoms temporarily to decide whether to undergo irreversible surgery or endoscopic treatment.Thirty patients were enrolled and underwent endoscopic endoloop pre-test treatment. The Primary outcome in this study was measured by the percent reduction in post-procedure GERD symptoms as evidenced by analysis of the GERD-HRQL (Health Related Quality of Life) questionnaire. The secondary outcomes included improvement in esophageal 24-hr pH monitoring, improvement in quality of life questionnaires and safety. Patient follow-up assessments were completed at 7 and 14 days post treatment.
详细描述
Gastroesophageal reflux disease (GERD) is a neuromuscular disorder with abnormal reflux of gastric contents into the esophagus.The most common symptoms are heartburn, dysphagia, and regurgitation.Due to less invasion, several endoscopic treatments of GERD have been investigated, such as collagen or radio frequency delivery, and antireflux mucosectomy(ARMS).The disadvantages of these treatment included short-term effectiveness, increasing reflux and ulcer, and serious complications. A novel endoscopic endoloop pre-test treatment has been developed, offering a minimally reversible endoscopic treatment to predict whether the symptoms can be alleviated in order to ultimately decide whether to undergo irreversible surgery or endoscopic treatment, which can be performed in an outpatient setting.The aim of this study was to assess the feasibility and safety of the pre-test treatment.
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
- •Patients with typical symptoms of GERD with symptomatic response to PPI therapy for ≥ 3 months
- •Patients considered for non-medical therapy, i.e. unwillingness to take life-long medication in medically-responding disease, suffering from medication side-effects or medically-intractable disease
- •Pathological esophageal acid exposure after discontinuation of medical therapy, proven by ambulatory 24-hour pH-monitoring with > 5% of time a pH < 4 and a symptom-association probability > 95%
- •written informed consent
排除标准
- •24 hr acid exposure study showing abnormal esophageal acid exposure <4%
- •DeMeester Score <14.7
- •hiatal hernia (> 3 cm in length)
- •history of antireflux or esophageal/gastric surgery
- •severe psychiatric disease
- •Barrett's esophagus with dysplasia
- •esophageal stenosis/malignancy
- •pregnancy or lactation
- •history of low therapeutic compliance
- •other severe comorbidity (including cardiopulmonary disease, portal hypertension, collagen diseases, morbid obesity, coagulation disorder)
- •use of anticoagulant or immunosuppressive drugs
结局指标
主要结局
Improvement in Reflux Symptom Index (RSI) questionnaire scores
时间窗: 1 month
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
Improvement in GERD-Health Related Quality of Life (HRQL) questionnaire scores
时间窗: 1 month
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
次要结局
- Effect on 24-hours esophageal pH-impedance(14 days)
- Changes in DeMeester score(14 days)
- Safety and Tolerability of the procedure(1 month)