Image-Enhanced Endoscopy (IEE) for Diagnosis of Non-Erosive Reflux Disease

NCT02629081 | Completed

• 2 other identifiers: HIC15030154860005
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

When treating persistent heartburn from gastroesophageal reflux disease (GERD) that does not respond to conventional treatment (a class of medications called proton pump inhibitors), it is important to be able to distinguish between erosive GERD and non-erosive GERD (called NERD). Currently the best method the investigators have to make this distinction is esophageal 24-hour pH and impedance testing. The test involves inserting a catheter into the esophagus through the nose and having the catheter maintained in this position for 24 hours This test is invasive, can be uncomfortable, and it is expensive and time consuming. The investigators are hoping that image enhanced technology will identify characteristics that are found more commonly in patients with non-erosive GERD compared to controls and therefore provide evidence that may allow us to replace pH and impedance testing with the image enhanced endoscopy as the best way to diagnose NERD. Participants will be either patients undergoing an upper endoscopy as part of their standard clinical evaluation for heartburn that does not respond to PPIs or patients undergoing standard clinical evaluation endoscopy for other reasons.

Conditions

GERD

Keywords

heartburn; GERD; NERD; non-erosive reflux disease

Outcome Measures

Primary Outcomes (1)

• Squamo-columnar junction vascularity (graded as present or absent by endoscopist using IEE)

  Once--at endoscopy

Secondary Outcomes (2)

• Presence or absence of micro-erosions identified by endoscopist using IEE

  Once at endoscopy

• Squamo-columnar junction pit pattern (graded as round or non-round by endoscopist using IEE)

  Once at endoscopy

Study Arms (1)

Controls & Cases

Controls (participants without heartburn or other GERD symptoms undergoing standard upper endoscopy for the following: anemia, weight loss, diarrhea, and screening for esophageal varices) and Cases (participants with heartburn or other GERD symptoms undergoing standard endoscopy for heartburn or other GERD symptoms.)

Other: Controls & Cases

Interventions

Controls & Cases OTHER

All interventions are standard of care and both controls and cases will be treated the same. IEE results from controls and cases will be compared.

Controls & Cases

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Controls (participants scheduled for upper endoscopy for anemia, weight loss, diarrhea, or screening for esophageal varices and who do not have heartburn or other GERD symptoms and Cases (participants scheduled for upper endoscopy for heartburn or other GERD symptoms.)

You may qualify if:

• Patients scheduled for an upper endoscopy for anemia, weight loss, diarrhea, or screening for esophageal varices without heartburn or other GERD symptoms and patients scheduled for upper endoscopy for heartburn not resolving with PPIs

You may not qualify if:

• Patients who have evidence of erosive esophagitis under white-light endoscopy
• Patients with Barrett's esophagus or esophageal malignancy on prior or current endoscopy
• Patients unable or unwilling to sign informed consent

Sponsors & Collaborators

• Loren Laine: lead

Study Sites (2)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

VACHS

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn; Non-Erosive Reflux Disease

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Loren Laine, MD

  Yale University, VACHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine, Digestive Diseases

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 11, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 12, 2016

Record last verified: 2016-07

Locations

US (2)