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OpenTrials
Completed

NCT Number: NCT01188980

Early Increase in Blood Supply 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.

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Key information

Conditions

Barrett's Esophagus Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. determine if early increase blood supply (EIBS)can predict presence of Dysplasia

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Acronym: EIBS in BE

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 26, 2010
Registry last updated
Apr 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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