Seattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients With Barrett's Esophagus Undergoing Surveillance
SWAT-BE
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)
1 other identifier
interventional
2,298
1 country
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2022
CompletedFirst Posted
Study publicly available on registry
September 7, 2022
CompletedStudy Start
First participant enrolled
October 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedJune 12, 2024
June 1, 2024
3.4 years
September 2, 2022
June 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Diagnostic yield of dysplasia (Surveillance population only)
Proportion of positive results between the Seattle protocol and WATS3D technique. Positive results include low-grade dysplasia (LGD), high-grade dysplasia (HGD), and esophageal adenocarcinoma (EAC). All positive results for dysplasia or EAC with WATS3D sampling not detected on Seattle biopsy protocol at index endoscopy will require confirmation by repeat sampling using the Seattle biopsy protocol.
up to 1 year
Diagnostic yield of intestinal metaplasia (Screening population only)
Proportion of positive results between the Seattle protocol and WATS3D technique. Positive results include intestinal metaplasia. All positive results for intestinal metaplasia/dysplasia or esophageal adenocarcinoma (EAC) with WATS3D sampling not detected on Seattle biopsy protocol at index endoscopy will require confirmation by repeat sampling using the Seattle biopsy protocol.
up to 1 year
Secondary Outcomes (9)
Detection of intestinal metaplasia (Surveillance population only)
baseline
Diagnostic yield between the Seattle protocol and WATS3D Vs. the Seattle protocol alone (Surveillance population only)
up to 1 year
Time of procedure as measured by total sampling time (Surveillance population only)
baseline
Quality adjusted life years (Surveillance population only)
up to 5 years
Number of patients referred for endoscopic eradication therapy (EET) between Seattle protocol and WATS3D (Surveillance population only)
up to 1 year
- +4 more secondary outcomes
Study Arms (2)
Seattle protocol, then WATS3D brushings.
OTHERParticipants in the screening or surveillance population that receive the Seattle protocol, then WATS3D brushings, during the same procedure.
WATS3D brushings, then Seattle Protocol.
OTHERParticipants in the screening or surveillance population that receive the WATS3D brushings, then the Seattle protocol, during the same procedure.
Interventions
Participants undergo 4-quadrant biopsies with standard biopsy forceps taken at 2 cm intervals. For participants undergoing a confirmatory endoscopy for cases in which discordant results are noted (WATS3D positive for dysplasia/cancer and Seattle biopsy negative for dysplasia/cancer), repeat biopsies will be taken at 1 cm intervals along with target biopsies from any visible lesions.
Participants undergo 2 WATS3D biopsies of every 5 cm segment of Barrett's esophagus, starting from the gastroesophageal junction and moving proximally through the entire segment of Barrett's.
Eligibility Criteria
You may qualify if:
- 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
- +1 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Arizona Centers of Digestive Health
Gilbert, Arizona, 85295, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90024, United States
Kaiser Permanente
Oakland, California, 94611, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Connecticut Clinical Research Institute
Bristol, Connecticut, 06010, United States
Suncoast Endoscopy of Sarasota
Sarasota, Florida, 34239, United States
Northwestern University
Chicago, Illinois, 60611, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
Weill Cornell Medicine
New York, New York, 10065, United States
University of Rochester
Rochester, New York, 14642, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Gastrointestinal Associates, PC
Knoxville, Tennessee, 37909, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sachin Wani, MD
University of Colorado, Denver
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2022
First Posted
September 7, 2022
Study Start
October 3, 2022
Primary Completion
March 1, 2026
Study Completion
March 1, 2026
Last Updated
June 12, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 9 months to 36 months following article publication.
- Access Criteria
- Researchers who provide a methodologically sound proposal and investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. These data can only be used for individual participant data meta-analysis.
Individual participant data that underlie the results reported in original publications after deidentification (text, tables, figures, appendixes).