Comparing two methods for sampling Barrett's esophagus
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)
This study is testing which method, the standard biopsy or a new sampling technique, is better at finding early signs of cancer in people with Barrett's esophagus.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2298 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 14 sites (Gilbert, Arizona and 13 other locations) |
| Trial ID | NCT05530343 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of the standard Seattle biopsy protocol against the wide-area transepithelial sampling (WATS3D) method in patients with Barrett's esophagus. Participants will undergo upper endoscopy with high-definition imaging, followed by randomization to receive one of the two sampling techniques. Both methods will be evaluated for their ability to detect dysplasia and potential early signs of esophageal adenocarcinoma. The study seeks to determine which sampling approach provides better diagnostic accuracy and patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-89 with non-dysplastic Barrett's esophagus undergoing surveillance or those being screened for Barrett's esophagus.
Not a fit: Patients with a history of high-grade dysplasia or esophageal adenocarcinoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection of dysplasia and esophageal adenocarcinoma in patients with Barrett's esophagus.
How similar studies have performed: Previous studies have shown varying success with different sampling techniques for Barrett's esophagus, making this approach both relevant and necessary for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: Surveillance Population * BE patients undergoing surveillance or evaluation for endoscopic eradication therapy (EET) for prior diagnosis of BE related dysplasia or esophageal adenocarcinoma (EAC) * Active erosive esophagitis with LA Grade B or higher * Esophageal varices * Prior history of EET * Prior history of esophageal or gastric surgery, except for uncomplicated fundoplication * Pregnancy Screening Population * BE patients undergoing surveillance or evaluation for EET for prior diagnosis for BE-related dysplasia or EAC * Active erosive esophagitis with LA Grade B or higher * Esophageal varices * Prior history of esophageal or gastric surgery, except for uncomplicated fundoplication * Pregnancy
Where this trial is running
Gilbert, Arizona and 13 other locations
- Arizona Centers of Digestive Health — Gilbert, Arizona, United States (Recruiting)
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
- Kaiser Permanente — Oakland, California, United States (Recruiting)
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
- Connecticut Clinical Research Institute — Bristol, Connecticut, United States (Recruiting)
- Suncoast Endoscopy of Sarasota — Sarasota, Florida, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Long Island Jewish Medical Center — New Hyde Park, New York, United States (Recruiting)
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
- University of Rochester — Rochester, New York, United States (Recruiting)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Geisinger Medical Center — Danville, Pennsylvania, United States (Recruiting)
- Gastrointestinal Associates, PC — Knoxville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Sachin Wani, MD — University of Colorado, Denver
- Study coordinator: Alexa R DeBord, MS
- Email: alexa.debord@cuanschutz.edu
- Phone: 303-724-0432
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.