Role of EndoFLIP in the Diagnostic Paradigm of Esophagogastric Junction Outflow Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 120
- 主要终点
- Symptom Resolution
研究概览
简要总结
The aim of this project is to identify if EndoFLIP can categorize and change the diagnosis in patients with EGJOO and if categorization with EndoFLIP can predict the response to treatment with botulinum toxin at 12 weeks post procedure. Our hypothesis is that there will be greater symptom resolution in the treatment versus control in the abnormal DI category. In addition, we hypothesize there will be less symptom resolution in the control group with an abnormal DI as compared to those with a normal DI who also receive no treatment.
详细描述
Esophagogastric Outflow Obstruction (EGJOO) is a newer diagnosis in which some patients' symptoms resolve spontaneously or with conservative treatment, while others require treatment with botulinum toxin injected into the lower esophageal sphincter. Currently, there is no way to distinguish these two groups of patients upon diagnosis. EndoFLIP (endolumenal functional lumen imaging probe) is a new technology that can measure the distensibility index (DI) of the lower esophageal sphincter. Data has suggested that normal and abnormal DI measurements can categorize these patients and guide treatment course (1). Our study looks to confirm this finding.
- Elsbernd et al. Clinical characteristics and treatment response of esophagogastric junction outflow obstruction. Gastroenterology 2019;156(6):S-1017.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosed with esophagogastric junction outflow obstruction by high resolution manometry
排除标准
- •previous upper gastrointestinal surgery
- •significant medical co-morbidities
- •eosinophilic esophagitis
- •severe reflux esophagitis (LA-classification C or D)
- •large hiatal hernia
- •patients experiencing significant weight loss suspicious for malignancy
- •Vulnerable populations such as cognitively or decisionally impaired individuals, children, pregnant women, prisoners, and students or employees of the University of Kansas Health System or Medical Center
研究组 & 干预措施
Abnormal DI - Botox
Patients' whose distensibility index is measured <2.8 will be injected with 100 units of botulinum toxin in the lower esophageal sphincter (25 units in each quadrant).
干预措施: Botulinum Toxin Type A Injection [Botox] (Drug)
结局指标
主要结局
Symptom Resolution
时间窗: 12 weeks.
The primary endpoint is the proportion of patients with complete symptom resolution at 12 weeks (Eckardt score \< 3) post procedure in each group.
次要结局
- Percent change in symptom score(12 weeks.)
- Mean symptom scores(12 weeks.)
研究者
Reza Hejazi
Principal Investigator
University of Kansas Medical Center