Barrett's Esophagus Related Neoplasia (BERN) Project (BERN)
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|ClinicalTrials.gov Identifier: NCT00590239|
Recruitment Status : Recruiting
First Posted : January 10, 2008
Last Update Posted : January 25, 2019
- 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 or disease|
|Barrett's Esophagus Neoplasms Gastroesophageal Reflux|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Endoscopic Detection of Early Neoplasia in Patients With Barrett's Esophagus|
|Study Start Date :||May 2007|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||December 2021|
- Video-atlas creation [ Time Frame: March 2007 - June 2016 ]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.
- Pathologic and Clinical Outcomes [ Time Frame: 2007 - 2016 ]To determine the pathologic and clinical outcomes of patients undergoing EMR / ablation; including morbidity, mortality and complications of the procedure.
- Interobserver agreement for the detection of early neoplasia [ Time Frame: 2015 - 2016 ]To determine the interobserver agreement using the video-atlas for the detection of early neoplasia.
- Efficacy of endoscopic detection of early esophageal lesions [ Time Frame: 2007-2016 ]To determine the endoscopic detection rate of early neoplastic lesions by expert endoscopists, experienced endoscopists, and trainees. The endoscopist will be graded as 1.) Trainees (in fellowship training); 2.) Experienced endoscopist (<5 yrs of experience in esophageal diseases); 3.) Expert endoscopist (>5 yrs of experience in esophageal diseases).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00590239
|Contact: April Higbee, BN||8168614700 ext 57456||April.Higbee@va.gov|
|United States, Missouri|
|Kansas city VA Medical center||Recruiting|
|Kansas City, Missouri, United States, 64128|
|Contact: April Higbee, RN 816-861-4700 ext 57456 firstname.lastname@example.org|
|Sub-Investigator: Amit Rastogi, MD|
|Sub-Investigator: Ajay Bansal, MD|
|Principal Investigator: Prateek Sharma, MD|
|Principal Investigator:||Prateek Sharma, MD||Kansas city VA Medical Center|