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

NCT01188980 | Completed

• 1 other identifier: 09-005328
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Barrett's Esophagus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• determine if EIBS can predict presence of BE in patients undergoing upper endoscopy

  10 minutes

Study Arms (3)

NoBE (control)

BE without dysplasia

BE with dysplasia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Mayo College of Medicine, Director of Endoscopy, Mayo Clinic Florida

Study Record Dates

• First Submitted: August 24, 2010
• First Posted: August 26, 2010
• Study Start: June 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 22, 2016

Record last verified: 2016-04

Locations

US (1)