Imaging Enhanced Endoscopy for the Screening of Barrett's Esophagus

NCT01976351 | Terminated

• 1 other identifier: 200907036R
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Imaging enhanced endoscopy can improve the efficacy of screening of Barrett's esophagus and predict its invasiveness. There is potentially molecular change over the Barrett's esophagus in this Chinese population. To evaluate the efficacy of imaging enhanced endoscopy for screening of Barrett's esophagus and evaluation of invasiveness

Conditions

Barrett's Esophagus

Keywords

Barrett's esophagus; image-enhanced endoscopy

Outcome Measures

Primary Outcomes (1)

• The relationship between the mucosal morphology by imaging enhanced endoscopy and the presence of high-grade intraepithelial neoplasia from non-dysplastic specialized intestinal metaplasia.

  Up to one month

Study Arms (1)

Barrett's esophagus

Patients were eligible for the study if they were scheduled for endoscopic examination at the National Taiwan University Hospital and its Yun-Lin branch, because of a BE, with or without a previous history of dysplasia. Exclusion criteria included patients who are younger than 20 years of age or patients with esophageal or cardiac varices or pregnant women.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients were eligible for the study if they were scheduled for endoscopic examination at the National Taiwan University Hospital and its Yun-Lin branch, because of a BE, with or without a previous history of dysplasia. Exclusion criteria included patients who are younger than 20 years of age or patients with esophageal or cardiac varices or pregnant women.

You may qualify if:

• suspected or a history of Barrett's esophagus for endoscopic exam

You may not qualify if:

• younger than 20 years of age
• patients with esophageal or cardiac varices
• pregnant women.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

A standardized endoscopic biopsy protocol was performed at sites with ESEM which usually appeared as a reddish discoloration in an otherwise relatively whitish esophageal mucosa. Two pieces of specimen were taken; one for histological confirmation and another one (preserved as frozen tissue) for DNA analysis or immuno-histochemical staining. Biopsy from gastric cardia was also taken for histological confirmation.

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

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

Study Officials

• Yi-Chia Lee, MD,Msc

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: November 5, 2013
• Study Start: September 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 5, 2013

Record last verified: 2013-10

Locations

TW (1)