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

Barrett's Esophagus Clinical Trial

— EIBS in BE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188980
• Other study ID #: 09-005328
• Status: Completed
• Phase: N/A
• First received: August 24, 2010
• Last updated: April 8, 2014
• Start date: June 2010
• Est. completion date: April 2013

Study information

• Verified date: April 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No