Functional Luminal Imaging Probe (FLIP) Topography Use in Patients With Scleroderma and Trouble Swallowing

Not Applicable

Withdrawn

• Conditions: Dysphagia; Scleroderma; GERD - Gastro-Esophageal Reflux Disease
• Interventions: Device: FLIP topography; Procedure: Upper Endoscopy

• Registration Number: NCT03270722
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2017-08-18
• Study First Submitted QC: 2017-08-30
• Study First Posted: 2017-09-01
• Study Start: 2018-01-01
• Primary Completion: 2020-05
• Study Completion: 2020-05
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-16
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients with scleroderma but no trouble swallowing	FLIP topography	-
patients with scleroderma but no trouble swallowing	Upper Endoscopy	-
patients with scleroderma and trouble swallowing	FLIP topography	-
patients with scleroderma and trouble swallowing	Upper Endoscopy	-
patients without scleroderma undergoing endoscopy	FLIP topography	-
patients without scleroderma undergoing endoscopy	Upper Endoscopy	-

Primary Outcome Measures

Name	Time	Method
FLIP topography pattern	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.

Secondary Outcome Measures

Name	Time	Method
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.	The investigators will look to see if FLIP topography lead to the recommendation of additional medicines and/or surgeries/procedures.

Trial Locations

Locations (1)

Stanford Healthcare; 🇺🇸 Redwood City, California, United States