Early Increase in Blood Supply in Patients With Barrett's Esophagus

Completed

• Conditions: Barrett's Esophagus

• Registration Number: NCT01188980
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-08-24
• Study First Submitted QC: 2010-08-25
• Study First Posted: 2010-08-26
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-21
• Last Update Posted: 2016-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
determine if early increase blood supply (EIBS)can predict presence of Dysplasia	10 minutes during standard upper endoscopy	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).

Secondary Outcome Measures

Name	Time	Method
determine if EIBS can predict presence of BE in patients undergoing upper endoscopy	10 minutes	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States