Endoscopic Esophageal Topography (Endoflip 2.0) Versus High-resolution Manometry (HRM)

GERD Clinical Trial

Official title:

Endoscopic Esophageal Topography (Endoflip 2.0) Versus High-resolution Manometry (HRM) in Pre-operative Evaluation of GERD; a Non-inferiority Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05089929
• Other study ID #: 2020H0057
• Status: Completed
• Start date: March 19, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to investigate the use of FLIP topography in patients undergoing evaluation for gastroesophageal reflux disease (GERD). This device allows the clinician to measure muscle activity in the esophagus during a routine upper endoscopy. The FLIP topography will be used to help detect movement disorders in the esophagus, and to examine differences in patient satisfaction between FLIP topography and the standard of care procedure, high resolution manometry (HRM).

Description:

The goal of the proposed research is to evaluate the endoscopic esophageal functional luminal imaging probe (FLIP) with topography (Endoflip® 2.0, Medtronic, USA) as a pre-operative diagnostic test to rule out significant esophageal dysmotility in patients with gastroesophageal reflux disease (GERD). Currently, the gold standard for pre-operative motility assessment is high resolution manometry (HRM), a trans-nasal catheter test performed in an awake patient that can be quite uncomfortable, and some patients cannot tolerate.1 Conversely, Endoflip can provide similar data in a sedated patient at the time of upper endoscopy, limiting discomfort and streamlining workup. While Endoflip has been used as a complimentary tool for clinical decision making in major motility disorders, its evaluation as a potential stand-alone pre-operative test in the GERD population has been limited. However, if FLIP topography reliably excludes major motility disorders, patients could proceed with fundoplication without undergoing the additional burden of high resolution manometry (HRM) testing. Unfortunately, as of now, there are insufficient data available to justify a change in clinical practice. As a result, FLIP topography has remained relegated to a purely complimentary role.

To investigate this question, the investigators will perform FLIP topography (Endoflip 2.0) analysis on all patients undergoing routine evaluation for gastroesophageal reflux disease at the time of their pre-operative EGD. Those patients with repetitive antegrade contractions (RACs) on FLIP topography will be classified as having normal motility, while any other pattern will be considered abnormal. All patients will additionally complete a standard pre-operative reflux evaluation including HRM, Upper GI series (UGI), 48-hour wireless pH testing, and baseline GERD quality of life surveys. The investigators will then compare the results of the FLIP topography measurements to the results of the gold standard high-resolution manometry (HRM) in terms of the ability of the FLIP topography to differentiate between normal and impaired esophageal function in GERD patients. Subjects will then be followed through their anti-reflux operations and post-operative outcomes will be tracked with standardized symptom questionnaires at 1, 2 and 6 months post-operatively to evaluate for post-operative dysphagia and quality of life.

The investigators hypothesize that FLIP topography (Endoflip 2.0) in GERD patients will reliably identify individuals with normal motility, which will predict good outcomes after anti-reflux surgery. If this proves to be the case, formal high resolution manometry (HRM) testing would not be necessary prior to proceeding with fundoplication, allowing a paradigm shift in the pre-operative workup of this large population of patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Suspected or known history of GERD

• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Previous esophageal or gastric surgery (including failed anti-reflux operation)

• Hiatal Hernia > 5cm based on upper GI

• Patients with a known major motility disorder (achalasia)

Related Conditions & MeSH terms

• GERD

Intervention

Device:
• Endoflip 2.0
FLIP topography (Endoflip 2.0) analysis will be performed on all patients undergoing routine evaluation for gastroesophageal reflux disease at the time of their pre-operative EGD.

Procedure:
• High Resolution Manometry
All patients undergoing routine evaluation for gastroesophageal reflux disease will undergo high resolution manometry (HRM) testing.

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluate patient satisfaction using study questionnaire	Evaluate patient satisfaction with the FLIP topography procedure compared to traditional High Resolution Manometry (HRM) testing using a questionnaire to rate pain, discomfort, and anxiety as "not at all", "a little", "some" or "a lot".	6 months
Other	Post-Fundoplication Dysphagia	Assess rates of post-fundoplication dysphagia in patients with and without RACs on FLIP topography as determined by GERD-HRQL (gastroesophageal reflux disease health-related quality of life) scale.	6 months
Primary	Concordance between the presence of RACs versus the absence of major motility disorder	Evaluate the concordance between the presence of RACs on FLIP topography versus the absence of major motility disorder on HRM as defined by the Chicago classification system v3.	6 months
Secondary	Concordance between the presence of RACs versus distal esophageal amplitude	Evaluate the concordance between the presence of RACs on FLIP topography versus the finding of distal esophageal amplitude >20mmHg as a surrogate for adequate esophageal function for Nissen fundoplication.	6 months