Clinical trial NCT03270722: Functional Luminal Imaging Probe (FLIP) Topography Use in Patients With Scleroderma and Trouble Swallowing
Official title: Use of FLIP Topography to Evaluate Esophageal Symptoms in Patients With Scleroderma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Scleroderma
Dysphagia
GERD - Gastro-Esophageal Reflux Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Currently, the FLIP topography device has been FDA cleared for esophageal distensibility testing. It has never been evaluated specifically in patients with scleroderma.

Eligibility criteria: Inclusion Criteria:

* Must have a clinical indication for upper endoscopy (recruiting patients both with scleroderma and without)

Exclusion Criteria:

* 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

Primary outcomes:
measure: FLIP topography pattern
timeFrame: 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).
Secondary outcomes:
measure: Change in medical management
timeFrame: Recommendations will be made directly after the procedure. Chart reviews at 6 months will also occur to monitor implementation of medical recommendations.
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Healthcare
state: California
Study officials:
References: