WATS3D vs Seattle Protocol for Barrett's Esophagus

(SWAT-BE Trial)

Recruiting in Palo Alto (17 mi)

+14 other locations

Overseen by Sachin Wani, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Colorado, Denver

Disqualifiers: Erosive esophagitis, Esophageal varices, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment WATS3D vs Seattle Protocol for Barrett's Esophagus?

Research shows that WATS3D, when used alongside the Seattle Protocol, significantly increases the detection of Barrett's esophagus and related abnormal cell growth compared to using the Seattle Protocol alone. This combination helps find more cases of Barrett's esophagus and dysplasia (abnormal cells that can lead to cancer), making it a more effective approach for monitoring this condition.

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How does the WATS3D treatment differ from the Seattle Protocol for Barrett's Esophagus?

WATS3D is a unique treatment for Barrett's Esophagus because it uses a brush biopsy device to extensively sample the esophagus and employs computer-assisted 3D analysis to improve the detection of abnormal cells, unlike the traditional Seattle Protocol which relies on random biopsies and can miss areas of concern.

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Eligibility Criteria

This trial is for English and Spanish speakers aged 18-89 with Barrett's esophagus (BE), specifically non-dysplastic BE or those previously diagnosed with low-grade dysplasia but now showing NDBE. Participants must have a life expectancy of at least 2 years, be able to consent, and are undergoing surveillance endoscopy. Excluded are individuals with severe erosive esophagitis, esophageal varices, history of certain surgeries, pregnancy, or previous high-grade dysplasia/esophageal cancer treatments.

Inclusion Criteria

I am being monitored for Barrett's esophagus without severe cell changes.

My doctor is trained and certified to use WATS3D for the study.

BE length of at least M1

Exclusion Criteria

I am being monitored or considered for treatment due to a previous diagnosis of Barrett's esophagus-related changes or esophageal cancer.

I have enlarged veins in my esophagus.

I have severe acid reflux damage in my esophagus.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endoscopic procedures using both the Seattle biopsy protocol and WATS3D to sample Barrett's esophagus

Single procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the endoscopic procedure, with potential repeat endoscopy if results are discordant

up to 1 year

Long-term follow-up

Participants are monitored for progression to dysplasia or esophageal adenocarcinoma and other outcomes

up to 5 years

Participant Groups

The study compares two methods for sampling tissue in patients with Barrett's Esophagus: the standard Seattle biopsy protocol and WATS3D brushings. The goal is to determine which method is more effective at detecting precancerous changes early on. Each participant will experience both procedures in a randomized order during their scheduled endoscopic surveillance.

Group I: WATS3D brushings, then Seattle Protocol. Experimental Treatment 2 Interventions

Participants in the screening or surveillance population that receive the WATS3D brushings, then the Seattle protocol, during the same procedure.

Group II: Seattle protocol, then WATS3D brushings. Experimental Treatment 2 Interventions

Participants in the screening or surveillance population that receive the Seattle protocol, then WATS3D brushings, during the same procedure.

Seattle protocol is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Seattle Biopsy Protocol for:

• Surveillance for Barrett's Esophagus
• Detection of Dysplasia and Esophageal Adenocarcinoma

🇪🇺 Approved in European Union as Seattle Biopsy Protocol for:

• Surveillance for Barrett's Esophagus
• Detection of Dysplasia and Esophageal Adenocarcinoma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of California, Los Angeles Los Angeles, CA

Weill Cornell Medicine New York, NY

University of Colorado Anschutz Medical Campus Aurora, CO

Gastrointestinal Associates, PC Knoxville, TN

More Trial Locations

Who Is Running the Clinical Trial?

University of Colorado, Denver Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Wide-area transepithelial sampling for dysplasia detection in Barrett's esophagus: a systematic review and meta-analysis. [2023] Seattle protocol forceps biopsy sampling (FB) is currently recommended for surveillance in Barrett's esophagus (BE) but limited by sampling error and lack of compliance. Wide-area transepithelial sampling with 3-dimensional analysis (WATS3D; CDx Diagnostics, Suffern, NY, USA) is reported to increase BE dysplasia detection. We assessed the incremental yield and clinical significance of WATS3D for dysplasia detection over FB in a systematic review and meta-analysis.

2. United States pubmed.ncbi.nlm.nih.gov

Wide Area Transepithelial Sampling with Computer-Assisted Analysis (WATS3D) Is Cost-Effective in Barrett's Esophagus Screening. [2021] Label="BACKGROUND">Wide area transepithelial sampling with three-dimensional computer-assisted analysis (WATS3D) is an adjunct to the standard random 4-quadrant forceps biopsies (FB, "Seattle protocol") that significantly increases the detection of Barrett's esophagus (BE) and associated neoplasia in patients undergoing screening or surveillance.

3. Greece pubmed.ncbi.nlm.nih.gov

Retrospective, observational, cross-sectional study of detection of recurrent Barrett's esophagus and dysplasia in post-ablation patients with adjunctive use of wide-area transepithelial sample (WATS-3D). [2022] Barrett's esophagus (BE) and dysplasia are often missed by Seattle protocol biopsies (SPB). Wide-area transepithelial sampling with 3-dimensional computer-assisted analysis (WATS-3D) with SPB improves detection in treatment-naïve patients. We aimed to determine to what extent WATS-3D adds to SPB in the detection of non-dysplastic BE (NDBE) and dysplasia in patients undergoing post-endoscopic eradication therapy (EET).

4. United States pubmed.ncbi.nlm.nih.gov

Role of Wide-Area Transepithelial Sampling With 3D Computer-Assisted Analysis in the Diagnosis and Management of Barrett's Esophagus. [2023] Barrett's esophagus (BE) is a premalignant condition in which cancer prevention is performed by endoscopic surveillance combined with Seattle protocol mucosal biopsies. The Seattle protocol has significant limitations, including a high rate of sampling error due to the focality of dysplasia/carcinoma, low endoscopist adherence to the protocol, and a high degree of variability in pathologic interpretation. These factors all contribute to a high incidence of cancers missed within 1 year of surveillance endoscopy. Wide-area transepithelial sampling with computer-assisted three-dimensional analysis (WATS3D) is a relatively new technique that minimizes sampling error by using a brush biopsy device that extensively samples "at risk" mucosa and helps pathologists diagnose dysplasia/neoplasia by generating three-dimensional images of whole crypts using a neural network-based software program. Several large prospective trials (involving both academic and community practices) have shown significantly increased rates of detection of dysplasia and intestinal metaplasia in both screening and surveillance in patients with BE when used as an adjunct to Seattle protocol-based forceps biopsies. The WATS3D diagnostic platform was included in the most recent American Society for Gastrointestinal Endoscopy Barrett's guideline as an adjunct to forceps biopsies (conditional recommendation and low quality of evidence). This review summarizes the scientific and pathologic basis of WATS3D technology, its potential impact on BE surveillance and management, and its limitations and future directions.

5. United States pubmed.ncbi.nlm.nih.gov

The Seattle protocol does not more reliably predict the detection of cancer at the time of esophagectomy than a less intensive surveillance protocol. [2022] The optimal management of high-grade dysplasia in Barrett's esophagus remains controversial. A biopsy protocol consisting of 4 quadrant jumbo biopsies (every 1 cm) with biopsies of mucosal abnormalities (the Seattle protocol) is considered to be the optimal method for detecting early cancers in patients with high-grade dysplasia, although it has never been validated. This study aimed to determine the frequency of unsuspected carcinoma at esophagectomy in Barrett's esophagus patients with high-grade dysplasia who underwent the Seattle protocol and to compare the findings with those of a less rigorous biopsy protocol.

6. Germany pubmed.ncbi.nlm.nih.gov

SAGES TAVAC safety and efficacy analysis WATS3D (CDx Diagnostics, Suffern, NY). [2021] Wide-area transepithelial sampling of the esophagus with computer-assisted three-dimensional analysis (WATS3D, CDx Diagnostics, Suffern, NY) is an adjunctive technique to random biopsies for early detection of Barrett's esophagus. The aim of the SAGES Technology and Value Assessment Committee aims is to evaluate the efficacy, value, and safety of WATS3D.