Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Barrett's Esophagus Related Neoplasia (BERN) Project

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Midwest Biomedical Research Foundation
Sponsor:
Collaborator:
Kansas City Veteran Affairs Medical Center
Information provided by (Responsible Party):
PRATEEK SHARMA, Midwest Biomedical Research Foundation
ClinicalTrials.gov Identifier:
NCT00590239
First received: December 26, 2007
Last updated: March 28, 2014
Last verified: March 2014
  Purpose
  • 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.


Condition
Barrett's Esophagus
Neoplasms
Gastroesophageal Reflux

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endoscopic Detection of Early Neoplasia in Patients With Barrett's Esophagus

Resource links provided by NLM:


Further study details as provided by Midwest Biomedical Research Foundation:

Estimated Enrollment: 150
Study Start Date: May 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 18-80 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590239

Contacts
Contact: April Higbee, BN 8168614700 ext 57456 April.Higbee@va.gov

Locations
United States, Missouri
Kansas city VA Medical center Recruiting
Kansas city, Missouri, United States, 64128
Contact: April Higbee, RN    816-861-4700 ext 57456    april.higbee@va.gov   
Sub-Investigator: Amit Rastogi, MD         
Sub-Investigator: Ajay Bansal, MD         
Principal Investigator: Prateek Sharma, MD         
Sponsors and Collaborators
Midwest Biomedical Research Foundation
Kansas City Veteran Affairs Medical Center
Investigators
Principal Investigator: Prateek Sharma, MD Kansas city VA Medical Center
  More Information

No publications provided

Responsible Party: PRATEEK SHARMA, Principal Investigator, Midwest Biomedical Research Foundation
ClinicalTrials.gov Identifier: NCT00590239     History of Changes
Other Study ID Numbers: PS0044
Study First Received: December 26, 2007
Last Updated: March 28, 2014
Health Authority: United States: Federal Government

Keywords provided by Midwest Biomedical Research Foundation:
Barrett's Esophagus
Neoplasia
Endoscopic mucosal resection
High resolution endoscopy
Chromoendoscopy

Additional relevant MeSH terms:
Barrett Esophagus
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on November 20, 2014