What this study is
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.
What's being tested
- Seattle protocol
Intervention · DIAGNOSTIC TEST
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.
- WATS3D brushings
Intervention · DIAGNOSTIC TEST
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.
Study details
- Official title
- 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)
- Sponsor
- University of Colorado, Denver
- Conditions
- Barrett Esophagus · Barretts Esophagus With Dysplasia · Esophageal Adenocarcinoma
- Enrolling
- 2,298 people
- Starts
- 2022-10-03
- Est. completion
- 2026-06
- Design
- Single-blind, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 89 YearsSex ALLHealthy volunteers Not acceptedYou 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 -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.
You can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (14)
14 openArizona Centers of Digestive Health
Gilbert, Arizona, United States
- Mankanwal Sachdev, MD · Contactmsachdev@azcdh.com
- Mankanwal Sachdev, MD · Principal investigator
- Virender Sharma, MD · Sub-investigator
RecruitingUCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
- Raman Muthusamy, MD · Contactraman@mednet.ucla.edu
- Contact310-825-1892
- Venkataraman Muthusamy, MD · Principal investigator
- Adarsh M Thaker, MD · Sub-investigator
- Kevin A Ghassemi, MD · Sub-investigator
RecruitingKaiser Permanente
Oakland, California, United States
- Howard Chang, MD · Contacthoward.y.chang@kp.org
- Howard Chang, MD · Principal investigator
- Gene Ma, MD · Sub-investigator
- Mitchell Liverant, MD · Sub-investigator
RecruitingUniversity of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
- Alexa DeBord, MS · Contact303-724-0432alexa.debord@cuanschutz.edu
- Sandra Boimbo, MPH · Contact303-724-8892sandra.boimbo@cuanschutz.edu
- Sachin Wani, MD · Principal investigator
- Steven Edmundowicz, MD · Sub-investigator
- Mihir Wagh, MD · Sub-investigator
- Paul Menard-Katcher, MD · Sub-investigator
RecruitingConnecticut Clinical Research Institute
Bristol, Connecticut, United States
- Salam Zakko, MD · Contactszakko@connecticutgi.org
- Salam Zakko, MD · Principal investigator
- Peter Bloom, MD · Sub-investigator
- Liam Zakko, MD · Sub-investigator
- Daniel Smiley, MD · Sub-investigator
- Mark Versland, MD · Sub-investigator
- Eddy Castillo, MD · Sub-investigator
- David Chaletsky, MD · Sub-investigator
RecruitingSuncoast Endoscopy of Sarasota
Sarasota, Florida, United States
- Scott Corbett, MD · Contact941-320-7327scott.corbett@FDHS.com
- Lisa Underwood · Contact941-952-1145 ext. 203lunderwood@suncoastendoscopy.com
- Scott Corbett, MD · Principal investigator
RecruitingNorthwestern University
Chicago, Illinois, United States
- Srinadh Komanduri, MD · Contact312-933-4873sri-komanduri@northwestern.edu
- Justeena Jojo · Contact312-926-4977justeena.jojo@northwestern.edu
- Srinadh Komanduri, MD · Principal investigator
RecruitingMayo Clinic
Rochester, Minnesota, United States
- Prasad Iyer, MD · Contact507-266-4338iyer.prasad@mayo.edu
- Melissa Passe · Contact(507) 255-8693passe.melissa@mayo.edu
- Prasad Iyer, MD · Principal investigator
- Cadman Leggett, MD · Sub-investigator
- Chamil Codipilly, MD · Sub-investigator
RecruitingLong Island Jewish Medical Center
New Hyde Park, New York, United States
- Molly Stewart, BS · Contact718-470-4667Mstewart8@northwell.edu
- Arvind Trindade, MD · Principal investigator
RecruitingWeill Cornell Medicine
New York, New York, United States
- Felice Schnoll-Sussman, MD · Contactfhs2001@med.cornell.edu
- Felice H Schnoll-Sussman, MD · Principal investigator
- Philip O Katz, MD · Sub-investigator
- Amir Soumekh, MD · Sub-investigator
RecruitingUniversity of Rochester
Rochester, New York, United States
- Vivek Kaul, MD · Contactvivek_kaul@urmc.rochester.edu
- Vivek Kaul, MD · Principal investigator
- Shivangi Kothari, MD · Sub-investigator
RecruitingUniversity of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
- Nicholas Shaheen, MD · Contactnicholas_shaheen@med.unc.edu
- Katie Danis · Contact(919) 843-5884
- Nicholas J Shaheen, MD · Principal investigator
- Swathi Eluri, MD · Sub-investigator
- Cary C Cotton, MD · Sub-investigator
RecruitingGeisinger Medical Center
Danville, Pennsylvania, United States
- Harshit Khara, MD · Contacthskhara@geisinger.edu
- Harshit Khara, MD · Principal investigator
- Joshua Obuch, MD · Sub-investigator
RecruitingGastrointestinal Associates, PC
Knoxville, Tennessee, United States
- Kathy Karnes, BSN, RN · Contact865-558-0687kkarnes@gihealthcare.com
- John M Haydek, MD · Principal investigator
- Raj I Narayani, MD · Sub-investigator
Recruiting
Study team
Sponsor
University of Colorado, Denver
Study ID 18-2431
Principal investigator
Sachin Wani, MD
University of Colorado, Denver
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.