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

GERD Clinical Trial

Official title:

Image-Enhanced Endoscopy for the Diagnosis of Non-Erosive Reflux Disease: A Prospective Case-Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02629081
• Other study ID #: HIC1503015486
• Secondary ID: 0005
• Status: Completed
• Phase: N/A
• First received: December 8, 2015
• Last updated: July 11, 2016
• Start date: March 2015
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

Evaluation of the utility of image-enhanced endoscopy (IEE) in the diagnosis of non-erosive reflux disease (NERD), defined as heartburn documented to be associated with reflux on impedance-pH testing in the absence of erosions on standard white-light endoscopy (WLE) during initial endoscopy.

The investigators will examine the following characteristics for IEE sensitivity, specificity, positive predictive values, and negative predictive value: squamo-columnar junction (SCJ) vascularity, micro-erosions, SCJ pit pattern, and combinations of these characteristics. The investigators will also look at abnormal morphology of intra-papillary capillary loops (IPCLS) using the newer generation Narrow Band Light (NBI-190 endoscopes and assess the identification of their presence using I-scan. Additionally, the investigators will examine real-time diagnostic yield of reflux diseases by IEE (in vivo diagnosis of reflux disease) and analyze obtained images and results to calculate inter-observer agreement.

IEE utilized will be commonly available I-scan (Pentax) and Narrow Band Imaging (Olympus).

Consecutive patients who meet eligibility criteria and are scheduled for upper endoscopy at locations specified in this record will be invited to participate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• GERD

Intervention

Other:
• Controls & Cases
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.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	VACHS	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Loren Laine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Squamo-columnar junction vascularity (graded as present or absent by endoscopist using IEE)		Once--at endoscopy	No
Secondary	Presence or absence of micro-erosions identified by endoscopist using IEE		Once at endoscopy	No
Secondary	Squamo-columnar junction pit pattern (graded as round or non-round by endoscopist using IEE)		Once at endoscopy	No