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

• Sponsor: Stanford University
• Information provided by (Responsible Party): Thomas Zikos, Stanford University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Scleroderma; Dysphagia; GERD - Gastro-Esophageal Reflux Disease	Device: FLIP topography; Procedure: Upper Endoscopy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Use of FLIP Topography to Evaluate Esophageal Symptoms in Patients With Scleroderma
• Actual Study Start Date: January 1, 2018
• Estimated Primary Completion Date: May 2020
• Estimated Study Completion Date: May 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: patients with scleroderma and trouble swallowing	Device: FLIP topography; During upper endoscopy, the FLIP topography balloon will be advanced into the esophagus and inflated, providing additional information about the distensibility of the esophagus. This generally takes about 5 extra minutes and no complications have been reported. Theoretical complications include bleeding, infection, risk with extra anesthesia time, and putting a hole in the esophagus.; Procedure: Upper Endoscopy; A standard upper endoscopy will also be done in all patients. A small scope will be passed via the mouth to examine the esophagus, stomach, and first part of the small intestine. The risks of this procedure include the risks associated with anesthesia, a small risk of bleeding, infection, and a very small risk of putting a hole in the gastrointestinal tract.; Other Name: EGD (esophagogastroduodenoscopy)
Experimental: patients with scleroderma but no trouble swallowing	Device: FLIP topography; During upper endoscopy, the FLIP topography balloon will be advanced into the esophagus and inflated, providing additional information about the distensibility of the esophagus. This generally takes about 5 extra minutes and no complications have been reported. Theoretical complications include bleeding, infection, risk with extra anesthesia time, and putting a hole in the esophagus.; Procedure: Upper Endoscopy; A standard upper endoscopy will also be done in all patients. A small scope will be passed via the mouth to examine the esophagus, stomach, and first part of the small intestine. The risks of this procedure include the risks associated with anesthesia, a small risk of bleeding, infection, and a very small risk of putting a hole in the gastrointestinal tract.; Other Name: EGD (esophagogastroduodenoscopy)
Active Comparator: patients without scleroderma undergoing endoscopy	Device: FLIP topography; During upper endoscopy, the FLIP topography balloon will be advanced into the esophagus and inflated, providing additional information about the distensibility of the esophagus. This generally takes about 5 extra minutes and no complications have been reported. Theoretical complications include bleeding, infection, risk with extra anesthesia time, and putting a hole in the esophagus.; Procedure: Upper Endoscopy; A standard upper endoscopy will also be done in all patients. A small scope will be passed via the mouth to examine the esophagus, stomach, and first part of the small intestine. The risks of this procedure include the risks associated with anesthesia, a small risk of bleeding, infection, and a very small risk of putting a hole in the gastrointestinal tract.; Other Name: EGD (esophagogastroduodenoscopy)

Outcome Measures

Primary Outcome Measures :

1. FLIP topography pattern [ Time Frame: 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 :

1. Change in medical management [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

Stanford Healthcare; Recruiting

Redwood City, California, United States, 94063

Contact: John O Clarke, MD 650-736-5555 jclarke2@stanford.edu

Principal Investigator: John Clarke, MD

Sub-Investigator: Nielson Fernandez-Becker, MD, PhD

Sub-Investigator: Lorinda Chung, MD

Sponsors and Collaborators

Stanford University

More Information

• Responsible Party: Thomas Zikos, Fellow in Gastroenterology, Stanford University
• ClinicalTrials.gov Identifier: NCT03270722 History of Changes
• Other Study ID Numbers: IRB-42435
• First Posted: September 1, 2017
• Last Update Posted: May 3, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: No
• Pediatric Postmarket Surveillance of a Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized; Gastroesophageal Reflux; Esophagitis, Peptic; Connective Tissue Diseases; Skin Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophagitis; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases