A Multicenter Randomized Trial of Seattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients With Barrett's Esophagus Undergoing Surveillance (The SWAT-BE Study)

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this research study is to learn about the best approach to sample patients with known or suspected Barrett's esophagus (BE) by comparing the standard Seattle biopsy protocol to sampling using wide area transepithelial sampling (WATS3D). Barrett's esophagus is a common condition that is used to spot patients at increased risk of developing a type of cancer in the esophagus (swallowing tube) called esophageal adenocarcinoma. The 5-year survival rate is as low as 18% for patients who get esophageal adenocarcinoma, but the rate may be improved if the cancer is caught in its early stages. Barrett's esophagus can lead to dysplasia, or precancerous changes, which occurs when cells look abnormal but have not developed into cancer. If the abnormal cells increase from being slightly abnormal (low-grade dysplasia), to being very abnormal (high-grade dysplasia), the risk of developing cancer (esophageal adenocarcinoma) goes up. Therefore, catching dysplasia early is very important to prevent cancer. Endoscopic surveillance is a type of procedure where endoscopists run a tube with a light and a camera on the end of it down a patients throat and remove a small piece of tissue. The piece of tissue, called a biopsy, is about the size of the tip of a ball-point pen and is checked for abnormal cells and cancer cells. Patients are being asked to be in this research study because they have been diagnosed with BE or suspected to have BE, and will need an esophagogastroduodenoscopy (EGD). Patients with BE undergo sampling using the Seattle biopsy protocol during which samples are obtained from the BE in a four quadrant fashion every 2 cm along with target biopsies from any abnormal areas within the BE. Another sampling approach is WATS3D which utilizes brushings from the BE. While both of these procedures are widely accepted approaches to sampling patients with BE during endoscopy, there is not enough research to show if one is better than the other. Participants in this study will undergo sampling of the BE using both approaches (Seattle biopsy protocol and WATS-3D); the order of the techniques will be randomized. Up to 2700 participants will take part in this research. This is a multicenter study involving several academic, community and private hospitals around the country.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:

‣ Surveillance Population

⁃ Undergoing surveillance endoscopy for a diagnosis of non-dysplastic Barrett's esophagus (NDBE, based on last endoscopic procedure; patients with prior history of low-grade dysplasia/indefinite for dysplasia with NDBE at last endoscopy can be included)

⁃ Barrett's esophagus (BE) length of at least M1

⁃ English and Spanish speaking

⁃ Able to comprehend and complete the consent form

⁃ Age18-89 years

⁃ Life-expectancy of at least 2 years

‣ Screening Population

⁃ Undergoing endoscopy for screening of BE

⁃ BE length of at least M1

⁃ English and Spanish speaking

⁃ Able to comprehend and complete the consent form

⁃ Age 18-89 years

⁃ Expected life-expectancy of at least 2 years

‣ Physicians

• All participating sites will include physicians who are trained in the use of WATS3D and certified by the site PI. All endoscopists will need to complete a minimum of three cases to be eligible to participate in the study.

Locations
United States
Arizona
Arizona Centers of Digestive Health
RECRUITING
Gilbert
California
UCLA / Jonsson Comprehensive Cancer Center
RECRUITING
Los Angeles
Kaiser Permanente
RECRUITING
Oakland
Colorado
University of Colorado Anschutz Medical Campus
RECRUITING
Aurora
Connecticut
Connecticut Clinical Research Institute
RECRUITING
Bristol
Florida
Suncoast Endoscopy of Sarasota
RECRUITING
Sarasota
Illinois
Northwestern University
RECRUITING
Chicago
Minnesota
Mayo Clinic
RECRUITING
Rochester
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
New York
Long Island Jewish Medical Center
RECRUITING
New Hyde Park
Weill Cornell Medicine
RECRUITING
New York
University of Rochester
RECRUITING
Rochester
Pennsylvania
Geisinger Medical Center
RECRUITING
Danville
Tennessee
Gastrointestinal Associates, PC
RECRUITING
Knoxville
Contact Information
Primary
Alexa R DeBord, MS
alexa.debord@cuanschutz.edu
303-724-0432
Backup
Sandra Boimbo, MPH
sandra.boimbo@cuanschutz.edu
303-724-8892
Time Frame
Start Date: 2022-10-03
Estimated Completion Date: 2026-03
Participants
Target number of participants: 2298
Treatments
Other: Seattle protocol, then WATS3D brushings.
Participants in the screening or surveillance population that receive the Seattle protocol, then WATS3D brushings, during the same procedure.
Other: WATS3D brushings, then Seattle Protocol.
Participants in the screening or surveillance population that receive the WATS3D brushings, then the Seattle protocol, during the same procedure.
Sponsors
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov

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