Recruiting

Observational Study

Sponsor:

Midwest Biomedical Research Foundation

Code:

NCT00590239

Conditions

Barrett's Esophagus

Neoplasms

Gastroesophageal Reflux

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT00590239

Start date

May 15, 2007

Status verified date

Nov, 2024

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Video-atlas creation [ Time Frame: March 2007 - June 2016 ]
  • Pathologic and Clinical Outcomes [ Time Frame: 2007 - 2016 ]

Central Contacts and Locations

Central contacts

Locations

Kansas city VA Medical center

Recruiting

Kansas City, Missouri, United States, 64128

Contacts

Principal Investigator:

Prateek Sharma, MD

More Information

Sponsor

Midwest Biomedical Research Foundation

Last update posted

Nov 22, 2024

Last verified

Nov, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Midwest Biomedical Research Foundation on 2024-11-22.