Recruiting

Seattle Biopsy Protocol vs. Wide-Area Transepithelial SamplingSeattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients With Barrett's Esophagus Undergoing Surveillance

Sponsor:

University of Colorado, Denver

Code:

NCT05530343

Conditions

Barrett Esophagus

Barretts Esophagus With Dysplasia

Esophageal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Seattle protocol

WATS3D brushings

Study Details

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.

Conditions

Barrett Esophagus

Barretts Esophagus With Dysplasia

Esophageal Adenocarcinoma

Study ID

NCT05530343

Start date

Oct 3, 2022

Status verified date

Jun, 2026

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2298 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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.

Interventions

Seattle protocol

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

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.

Primary outcome measure

Diagnostic yield of dysplasia (Surveillance population only) [ Time Frame: up to 1 year ]
Diagnostic yield of intestinal metaplasia (Screening population only) [ Time Frame: up to 1 year ]

Central Contacts and Locations

Central contacts

Alexa R DeBord, MS

303-724-0432 alexa.debord@cuanschutz.edu

Sandra Boimbo, MPH

303-724-8892 sandra.boimbo@cuanschutz.edu

Locations

Arizona Centers of Digestive Health

Recruiting

Gilbert, Arizona, United States, 85295

Contacts

Mankanwal Sachdev, MD

msachdev@azcdh.com

Principal Investigator:

Mankanwal Sachdev, MD

UCLA / Jonsson Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90024

Contacts

Raman Muthusamy, MD

raman@mednet.ucla.edu

310-825-1892

Principal Investigator:

Venkataraman Muthusamy, MD

Kaiser Permanente

Recruiting

Oakland, California, United States, 94611

Contacts

Howard Chang, MD

howard.y.chang@kp.org

Principal Investigator:

Howard Chang, MD

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Alexa DeBord, MS

303-724-0432 alexa.debord@cuanschutz.edu

Sandra Boimbo, MPH

303-724-8892 sandra.boimbo@cuanschutz.edu

Principal Investigator:

Sachin Wani, MD

Connecticut Clinical Research Institute

Recruiting

Bristol, Connecticut, United States, 06010

Contacts

Salam Zakko, MD

szakko@connecticutgi.org

Principal Investigator:

Salam Zakko, MD

Suncoast Endoscopy of Sarasota

Recruiting

Sarasota, Florida, United States, 34239

Contacts

Scott Corbett, MD

941-320-7327 scott.corbett@FDHS.com

Lisa Underwood

941-952-1145 lunderwood@suncoastendoscopy.com

Principal Investigator:

Scott Corbett, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Srinadh Komanduri, MD

312-933-4873 sri-komanduri@northwestern.edu

Justeena Jojo

312-926-4977 justeena.jojo@northwestern.edu

Principal Investigator:

Srinadh Komanduri, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Prasad Iyer, MD

507-266-4338 iyer.prasad@mayo.edu

Melissa Passe

(507) 255-8693 passe.melissa@mayo.edu

Principal Investigator:

Prasad Iyer, MD

Long Island Jewish Medical Center

Recruiting

New Hyde Park, New York, United States, 11040

Contacts

Molly Stewart, BS

718-470-4667 Mstewart8@northwell.edu

Principal Investigator:

Arvind Trindade, MD

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Felice Schnoll-Sussman, MD

fhs2001@med.cornell.edu

Principal Investigator:

Felice H Schnoll-Sussman, MD

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Vivek Kaul, MD

vivek_kaul@urmc.rochester.edu

Principal Investigator:

Vivek Kaul, MD

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Nicholas Shaheen, MD

nicholas_shaheen@med.unc.edu

Katie Danis

(919) 843-5884

Principal Investigator:

Nicholas J Shaheen, MD

Geisinger Medical Center

Recruiting

Danville, Pennsylvania, United States, 17822

Contacts

Harshit Khara, MD

hskhara@geisinger.edu

Principal Investigator:

Harshit Khara, MD

Gastrointestinal Associates, PC

Recruiting

Knoxville, Tennessee, United States, 37909

Contacts

Kathy Karnes, BSN, RN

865-558-0687 kkarnes@gihealthcare.com

Principal Investigator:

John M Haydek, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

Barrett's Esophagus
Esophageal Adenocarcinoma
Dysplasia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-07-01.