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

NCT ID: NCT03270722

Last Updated: 2021-01-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2020-05-31

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.

Conditions

Scleroderma; Dysphagia; GERD - Gastro-Esophageal Reflux Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

patients with scleroderma and trouble swallowing

Group Type: EXPERIMENTAL

FLIP topography

Intervention Type: DEVICE

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.

Upper Endoscopy

Intervention Type: PROCEDURE

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.

patients with scleroderma but no trouble swallowing

Group Type: EXPERIMENTAL

FLIP topography

Intervention Type: DEVICE

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.

Upper Endoscopy

Intervention Type: PROCEDURE

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.

patients without scleroderma undergoing endoscopy

Group Type: ACTIVE_COMPARATOR

FLIP topography

Intervention Type: DEVICE

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.

Upper Endoscopy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Other Intervention Names

EGD (esophagogastroduodenoscopy)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Thomas Zikos

Fellow in Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford Healthcare

Redwood City, California, United States

Countries

United States

Other Identifiers

IRB-42435

Identifier Type: -

Identifier Source: org_study_id