Functional Luminal Imaging Probe (FLIP) Topography Use in Patients With Scleroderma and Trouble Swallowing
| Status: | Recruiting |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease , Skin and Soft Tissue Infections, Gastrointestinal, Dermatology, Dermatology, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 1/31/2018 |
| Start Date: | January 1, 2018 |
| End Date: | May 2019 |
Use of FLIP Topography to Evaluate Esophageal Symptoms in Patients With Scleroderma
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.
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.
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.
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.
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
We found this trial at
1
site
Stanford, California 94305
Principal Investigator: John Clarke, MD
Phone: 650-736-5555
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