Use of FLIP Topography to Evaluate Esophageal Symptoms in Patients With Scleroderma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- FLIP topography pattern
研究概览
简要总结
FLIP topography has been FDA cleared to evaluate a variety of esophageal conditions, but has never been evaluated in patients with scleroderma. The investigators hope to evaluate this technology in patients who have scleroderma and various esophageal symptoms, and compare to non-scleroderma patients.
详细描述
In patients with treatment refractory reflux disease, dysphagia (trouble swallowing) or other symptoms possibly attributed to the esophagus, the standard protocol is generally to first do an upper endoscopy to evaluate for abnormalities. If this is normal the next step is often to do esophageal manometry to measure esophageal muscle contractions, along with a Ph/impedance study in certain clinical situations. If these are normal, then the the disorder is thought to be functional (no clear biological pathology). However, it is believed that FLIP (Functional Luminal Imaging Probe) technology may pick up additional disorders of the esophagus missed by standard esophageal manometry, leading to different treatments in certain cases. Additionally, FLIP technology offers a different approach to classifying motility disorders of the esophagus.
FLIP is a technology that measures distensibility and diameter of the esophagus during endoscopy by inflating a balloon in the esophagus. It has previously been used to aid in the diagnosis and provide more information regarding gastroesophageal reflux disease, achalasia, and eosinophilic esophagitis. It has also been used pre and post fundoplication and myotomy to assess adequacy of these procedure.
More recently a group at northwestern has developed a modification of this procedure called FLIP topography. The basic principles are the same, but this technique measures the reaction of the esophagus to distension, providing additional information.
A recent study of FLIP topography looked at 145 patients referred for dysphagia (trouble swallowing). All patients had both standard manometry and FLIP topography. 25% of patients in the study had a normal manometry, offering no measurable explanation of their symptoms. Of these patients, half had an abnormal FLIP topography, and additional treatments were offered in certain situations.
FLIP topography has also been evaluated in patients with eosinophilic esophagitis, though numbers are small.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a clinical indication for upper endoscopy (recruiting patients both with scleroderma and without)
排除标准
- •not healthy enough to undergo an upper endoscopy
- •mass, stricture, ring, or web present on upper endoscopy
- •history of esophageal cancer
- •history of esophageal surgery
结局指标
主要结局
FLIP topography pattern
时间窗: Will be analyzed directly after the procedure for an individual patient within 2 weeks. Comparisons within and between the 3 groups will be done at the conclusion of the study (once 60 total patients have been recruited).
This is the readout or topographic map that is generated from the FLIP topography diagnostic procedure. We will look to see if we can make additional diagnoses not made by other clinical testing, to see if the diagnoses made by FLIP topography match with other diagnostic testing, and identify new FLIP topography patterns in patients with scleroderma not seen before.
次要结局
- Change in medical management(Recommendations will be made directly after the procedure. Chart reviews at 6 months will also occur to monitor implementation of medical recommendations.)
研究者
Thomas Zikos
Fellow in Gastroenterology
Stanford University