Endoscopic Detection of Dysplasia in Barrett's Esophagus
High Resolution Magnifying Endoscopy and Contrast Enhanced Imaging Versus Standard White Light Endoscopy for the Detection of Dysplasia in Barrett's Esophagus. A Prospective Blinded Cross-over Study.
1 other identifier
interventional
111
1 country
1
Brief Summary
The purpose of this study is to determine whether High Resolution Magnification Endoscopy (HRME) and Computed Virtual Chromoendoscopy (CVC) with targeted biopsies is superior to conventional white light endoscopy (WLE) with 4 quadrant biopsies of the metaplastic epithelium every 1-2 cm (Seattle Protocol) for detection of pre-malignant lesions in patients with Barrett's Esophagus (BE).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 17, 2012
CompletedFirst Posted
Study publicly available on registry
September 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFebruary 10, 2014
February 1, 2014
3 years
September 17, 2012
February 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of detected dysplasia by each endoscopic technique.
Up to 36 months.
Secondary Outcomes (2)
The yield of low- and/or high-grade dysplasia by each endoscopic technique.
Up to 36 months.
The number of biopsies taken and the duration of the different endoscopic techniques.
Up to 36 months.
Other Outcomes (1)
The endoscopic prediction capability of present dysplasia compared to histopathology for HRME.
Up to 36 months.
Study Arms (2)
Introductory conventional endoscopy
ACTIVE COMPARATORConventional endoscopy followed by HRME+CVC after 30 days.
Introductory HRME+CVC
ACTIVE COMPARATORHRME+CVC followed by conventional endoscopy after 30 days.
Interventions
High resolution magnification endoscopy with computed virtual chromoendoscopy and directed biopsy
Conventional white light endoscopy with four-quadrant biopsy
Eligibility Criteria
You may qualify if:
- Presence of specialized intestinal metaplasia in biopsies from the esophagus
You may not qualify if:
- Dysplasia or cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Göteborg Universitylead
- Sahlgrenska University Hospitalcollaborator
Study Sites (1)
Gastrointestinal Endoscopy Unit, Sahlgrenska University Hospital
Gothenburg, S-41345, Sweden
Related Publications (1)
Bratlie SO, Johnsson E, Jonsson C, Fandriks L, Edebo A. Multiple-Band Imaging Provides Better Value Than White-light Endoscopy in Detection of Dysplasia in Patients With Barrett's Esophagus. Clin Gastroenterol Hepatol. 2015 Jun;13(6):1068-74.e2. doi: 10.1016/j.cgh.2014.12.007. Epub 2014 Dec 11.
PMID: 25499989DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Anders F Edebo, MD, PhD
Dept. Gastrosurgical Research and Education, Inst. Clinical Sciences, Sahlgrenska Academy, Gothenburg, Sweden
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2012
First Posted
September 27, 2012
Study Start
November 1, 2009
Primary Completion
November 1, 2012
Study Completion
January 1, 2013
Last Updated
February 10, 2014
Record last verified: 2014-02