Barrett's Esophagus Related Neoplasia (BERN) Project

NCT00590239 | Recruiting

• 1 other identifier: PS0044
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

• The use of high resolution endoscopy (HRE), narrow band imaging (NBI) and chromoendoscopy increases the detection rates of Barrett's esophagus (BE) and early neoplasia.
• Endoscopic mucosal resection (EMR) will improve the accuracy for detection of dysplasia/early neoplasia. Specific Aim 1 - To create a video-atlas of non-dysplastic and dysplastic/early neoplastic lesions in patients with BE. This will be used for training purposes and to assess learning curve associated with these new technologies. Specific Aim 2 - To create a standardized classification system for the mucosal and vascular patterns observed in patients with BE. Specific Aim 3 - To determine the interobserver agreement using the video-atlas for the mucosal and vascular patterns classification agreed upon. Specific Aim 4 - To determine the endoscopic detection rate of esophageal cancer or precancerous lesions removed during endoscopy. Specific Aim 5 - To determine the pathologic and clinical outcomes of patients undergoing EMR/ablation; including morbidity, mortality and complications of the procedure. Results to date (June 2008) : this study is active and open to enrollment. Currently 26 patients have enrolled in this study at the Kansas City VA medical center. In order to participate, patients must be eligible for care at the KCVA hospital.

Conditions

Barrett's Esophagus; Neoplasms; Gastroesophageal Reflux

Keywords

Barrett's Esophagus; Neoplasia; Endoscopic mucosal resection; High resolution endoscopy; Chromoendoscopy

Outcome Measures

Primary Outcomes (2)

• Video-atlas creation

  To create a video-atlas of early neoplastic lesions in patients with BE. This will be used for training purposes and to assess learning curve associated with these new technologies.

  March 2007 - June 2016

• Pathologic and Clinical Outcomes

  To determine the pathologic and clinical outcomes of patients undergoing EMR / ablation; including morbidity, mortality and complications of the procedure.

  2007 - 2016

Secondary Outcomes (2)

• Interobserver agreement for the detection of early neoplasia

  2015 - 2016

• Efficacy of endoscopic detection of early esophageal lesions

  2007-2016

Eligibility Criteria

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

Study Population

The study population is a Veteran population presenting to a VA Hospital upper endoscopy unit

You may qualify if:

• years
• Patients must be able to provide written informed consent
• Patients referred for endoscopy for screening/surveillance of BE or for endoscopic treatment of BE with early mucosal neoplasia

You may not qualify if:

• Current use of aspirin, non-steroidal anti-inflammatory agents(NSAIDs),or chronic anticoagulants that cannot be discontinued prior to the procedure.
• Inability to provide written informed consent
• Significant thrombocytopenia or coagulopathy
• Any significant co-morbid condition that would prevent the safe administration of conscious sedation

Sponsors & Collaborators

• Midwest Biomedical Research Foundation: lead
• Kansas City Veteran Affairs Medical Center: collaborator

Study Sites (1)

Kansas city VA Medical center

Kansas City, Missouri, 64128, United States

RECRUITING

MeSH Terms

Conditions

Barrett Esophagus; Neoplasms; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Precancerous Conditions; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophageal Motility Disorders; Deglutition Disorders

Study Officials

• Prateek Sharma, MD

  Kansas City VA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

April Higbee, BN

CONTACT

8168614700; April.Higbee@va.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 10, 2008
• Study Start: May 15, 2007
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)