Early Increase in Blood Supply in Patients With Barrett's Esophagus (EIBS in BE)

Detectable Esophageal Early Increase in Blood Supply (EIBS) in Patients With Barrett's Esophagus

The purpose of this study is to determine if early Barrett's specialized intestinal metaplasia can be detected by measuring early increased blood supply of the esophageal tissue, with 4 Dimensional Elastic Light-Scattering Fingerprinting, (4D-ELF) technology in real time.

Study Overview

• Status: Completed
• Conditions: Barrett's Esophagus

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Control Population: Patients with no Barrett's metaplasia scheduled for upper endoscopy at Mayo Clinic Jacksonville.

Experimental Population: Patients with biopsy-proven Barrett's esophagus and previously scheduled for upper endoscopy at Mayo Clinic Jacksonville.

Description

Inclusion Criteria:

• age 18 years or older,
• informed written consent,
• patient scheduled for previously planned upper endoscopy

Exclusion Criteria:

• liver disease;
• gastric antral vascular ectasia (GAVE);any known non-esophageal aerodigestive malignancy;
• severe cardiopulmonary disease precluding endoscopy; presence of conditions not allowing biopsy (e.g. coagulation disorder);
• known familial polyposis syndrome (FAP, HNPCC, Juvenile polyposis, etc.);
• known pregnancy or sexually active females of childbearing age who are not practicing an accepted form of birth control.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
NoBE (control)
BE without dysplasia
BE with dysplasia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
determine if early increase blood supply (EIBS)can predict presence of Dysplasia	To determine if early increase blood supply (EIBS), as measured in Barrett's glandular mucosa segment, can predict the presence of Dysplasia in patients with known diagnosis of Barrett's esophagus (BE).	10 minutes during standard upper endoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
determine if EIBS can predict presence of BE in patients undergoing upper endoscopy	EIBS measurements taken from buccal mucosa and esophagus will be compared in patients without BE, patients with BE without dysplasia, and patients with BE dysplasia. EIBS measurements will be obtained from normal squamous mucosa in the mouth, proximal esophagus, areas of BE in the distal esophagus, and measurements from the gastric cardia/hiatal hernia (at least 4 cm below the Z line.	10 minutes

Collaborators and Investigators

• Sponsor: Mayo Clinic

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: August 24, 2010
• First Submitted That Met QC Criteria: August 25, 2010
• First Posted (Estimate): August 26, 2010

Study Record Updates

• Last Update Posted (Estimate): April 22, 2016
• Last Update Submitted That Met QC Criteria: April 21, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: 09-005328