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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01188980

Acronym

EIBS in BE

Enrollment

Registered

2010-08-26

Start date

2010-06-30

Completion date

2013-04-30

Last updated

2016-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett's Esophagus

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results