RecruitingNot ApplicableNCT05530343

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

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

Enrollment

2,298 participants

Start Date

Oct 3, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two methods of taking tissue samples during an endoscopy (a camera procedure) for people with Barrett's esophagus, a condition where the lining of the food pipe changes and can become cancerous. You may be eligible if... - You are between 18 and 89 years old - You have been diagnosed with Barrett's esophagus (a change in the lining of your swallowing tube) or are being screened for it - Your Barrett's esophagus segment is at least a certain minimum length - You speak English or Spanish - You are expected to live at least 2 more years You may NOT be eligible if... - You are being evaluated for advanced treatment (like endoscopic eradication) due to prior pre-cancer or cancer in the esophagus - You have active, severe esophageal irritation, esophageal veins (varices), or a history of esophageal or stomach surgery - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTSeattle 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.

DIAGNOSTIC_TESTWATS3D 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.


Locations(14)

Arizona Centers of Digestive Health

Gilbert, Arizona, United States

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Kaiser Permanente

Oakland, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Connecticut Clinical Research Institute

Bristol, Connecticut, United States

Suncoast Endoscopy of Sarasota

Sarasota, Florida, United States

Northwestern University

Chicago, Illinois, United States

Mayo Clinic

Rochester, Minnesota, United States

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Weill Cornell Medicine

New York, New York, United States

University of Rochester

Rochester, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

Gastrointestinal Associates, PC

Knoxville, Tennessee, United States

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NCT05530343


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