WATS3D vs Seattle Protocol for Barrett's Esophagus

(SWAT-BE Trial)

Recruiting at 14 trial locations

Overseen By Sandra Boimbo, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Erosive esophagitis, Esophageal varices, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Single procedure

2298 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to take tissue samples from individuals with Barrett's esophagus, a condition that can increase the risk of esophageal cancer. It compares two methods: the Seattle protocol, which involves taking small tissue samples at regular intervals, and WATS3D, which uses a special brush to collect cells. The goal is to determine which method better detects early changes that could lead to cancer. Individuals diagnosed with Barrett's esophagus or suspected to have it and requiring an endoscopy might be suitable for this study. Participants will undergo both sampling methods in a random order during their endoscopy. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance early cancer detection methods.

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 prior data suggests that these sampling techniques are safe for patients with Barrett's esophagus?

Research shows that WATS3D brushings are generally well-tolerated. This method helps detect abnormal cells in the esophagus, crucial for identifying early pre-cancerous changes. Although the procedure involves brushing the esophagus, reports of serious side effects are rare, indicating it is a safe option for checking Barrett's esophagus, a condition where stomach acid damages the esophagus lining.

The Seattle biopsy protocol, a standard method for detecting abnormal cells in Barrett's esophagus, involves taking small tissue samples. It is widely accepted in medical practice as safe, with most people experiencing little risk of serious side effects.

Both methods are accepted and generally safe for patients undergoing an endoscopy, a procedure using a tube with a camera to examine the esophagus. For those considering joining a trial using these methods, evidence suggests they are generally safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two methods for detecting Barrett's Esophagus: the traditional Seattle protocol and the WATS3D brushings. The Seattle protocol involves taking multiple biopsies, which can be time-consuming and may miss abnormal cells. In contrast, WATS3D uses a special brush to collect cells from a larger surface area, potentially increasing detection accuracy and efficiency. By evaluating these two techniques head-to-head, researchers hope to determine which method is better at identifying precancerous changes, ultimately improving patient outcomes.

What evidence suggests that this trial's sampling techniques could be effective for Barrett's esophagus?

This trial will compare the effectiveness of WATS3D brushings and the Seattle protocol for detecting abnormal cells in Barrett's esophagus. Research has shown that WATS3D brushings can identify more abnormal cells in individuals with Barrett's esophagus. Studies have found that using WATS3D alongside regular biopsy methods increases the detection of dysplasia, which are early changes that could lead to cancer. Detecting these changes early is crucial to prevent them from developing into cancer. The WATS3D method employs a special brush to collect cells, which are then analyzed with computer assistance to identify any issues. This method has proven effective in finding abnormal cells in patients with Barrett's esophagus. ^{1 4 6 7 8}

Who Is on the Research Team?

Sachin Wani, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Seattle protocol
• WATS3D brushings

Trial Overview 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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

WATS3D sampling increased the detection of dysplasia in Barrett's esophagus by 7.2% compared to forceps biopsy (FB), indicating its potential to improve surveillance outcomes.

Despite the increased detection rate, WATS3D was negative in 62.5% of cases where FB identified dysplasia, raising questions about the clinical significance of the additional dysplasia detected by WATS3D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wide-area transepithelial sampling for dysplasia detection in Barrett's esophagus: a systematic review and meta-analysis. Codipilly, DC., Krishna Chandar, A., Wang, KK., et al.[2023]

Adding wide area transepithelial sampling with three-dimensional computer-assisted analysis (WATS3D) to the standard Seattle protocol significantly increases the detection of Barrett's esophagus and related cancers in patients with gastroesophageal reflux disease (GERD).

The cost-effectiveness analysis showed that using WATS3D alongside the Seattle protocol is more cost-effective, with an incremental cost-effectiveness ratio (ICER) of $71,395 per quality-adjusted life year (QALY), making it a viable option for screening in 60-year-old white male GERD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wide Area Transepithelial Sampling with Computer-Assisted Analysis (WATS3D) Is Cost-Effective in Barrett's Esophagus Screening. Singer, ME., Smith, MS.[2021]

In a study of 33 patients with high-grade dysplasia in Barrett's esophagus, the Seattle biopsy protocol (4 quadrant jumbo biopsies every 1 cm) did not significantly increase the detection of unsuspected intramucosal cancer compared to a less rigorous protocol (4 quadrant biopsies every 2 cm).

Both biopsy protocols revealed similar rates of unsuspected cancer at esophagectomy, with 40% in the Seattle group and 30% in the less intensive group, suggesting that the extensive sampling of the Seattle protocol may not be necessary for effective cancer detection.

NCBI (Pubmed)

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. Kariv, R., Plesec, TP., Goldblum, JR., et al.[2022]

In a study of 78 patients undergoing post-endoscopic eradication therapy, the use of WATS-3D in addition to Seattle protocol biopsies significantly improved the detection rates of non-dysplastic Barrett's esophagus (NDBE) by 26.9% and dysplasia/neoplasia by 6.4%.

The findings suggest that WATS-3D can double the yield of detecting NDBE and increase dysplasia detection by 167%, highlighting its potential as a valuable tool in monitoring patients after treatment for Barrett's esophagus.

NCBI (Pubmed)

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). Fatima, H., Wajid, M., Hamade, N., et al.[2022]

WATS3D is a safe technique with no significant morbidity or mortality reported, making it a reliable option for detecting Barrett's esophagus and related conditions.

This method significantly increases the diagnostic yield for Barrett's esophagus and dysplasia, with improvements ranging from 38-150% for Barrett's and up to 420% for high-grade dysplasia compared to traditional forceps biopsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SAGES TAVAC safety and efficacy analysis WATS3D (CDx Diagnostics, Suffern, NY). Docimo, S., Al-Mansour, M., Tsuda, S.[2021]

Wide-area transepithelial sampling with computer-assisted three-dimensional analysis (WATS3D) significantly improves the detection rates of dysplasia and intestinal metaplasia in patients with Barrett's esophagus compared to traditional Seattle protocol biopsies, as shown in several large prospective trials.

WATS3D is recommended as an adjunct to forceps biopsies in the latest American Society for Gastrointestinal Endoscopy guidelines, highlighting its potential to enhance cancer prevention strategies in Barrett's esophagus management.

NCBI (Pubmed)

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. Odze, RD., Goldblum, J., Kaul, V.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8053177/

Wide Area Transepithelial Sampling with Computer ... Wide Area Transepithelial Sampling with Computer-Assisted Analysis (WATS3D) Is Cost-Effective in Barrett's Esophagus Screening · Abstract · Introduction · Methods.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2949708622000115

Utility of wide-area transepithelial sampling with 3 ... WATS-3D is effective at increasing the diagnostic yield of IM and dysplasia in BE patients after EET when used as an adjunct to FB sampling.

3. cdxdiagnostics.com cdxdiagnostics.com/news/wats3d-segment-length-study-published

New study shows that WATS3D increases diagnostic yield ... New study shows that WATS3D increases diagnostic yield of dysplasia in Barrett's esophagus, regardless of segment length.

4. giejournal.org giejournal.org/article/S0016-5107(23)00373-5/fulltext

Benefit of adjunctive wide-area transepithelial sampling ... This study shows that when WATS-3D is added as an adjunct to forceps biopsies, it is effective at increasing the diagnostic yield of both BE and associated ...

5. ucla.clinicaltrials.researcherprofiles.org ucla.clinicaltrials.researcherprofiles.org/trial/NCT05056051

UCLA Barrett's Esophagus Trial → Wide-Area Transepithelial ... Regardless of stage of disease at time of diagnosis, the 5-year survival for EAC is an abysmal 19%. Endoscopic eradication therapy (EET) has ...

6. cdxdiagnostics.com cdxdiagnostics.com/wats3d

AI-Powered Detection of Pre-Cancerous Esophageal Cells WATS3D empowers physicians to preempt cancer. · WATS3D increased the overall detection of esophageal dysplasia by 242% and Barrett's by 153%. · Browse Clinical ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05056051

Study Details | NCT05056051 | Wide-Area Transepithelial ... WATS-3D involves abrasive brush sampling of the esophagus that is then processed by a validated computer imaging system and subsequently reviewed by pathologist ...

8. sages.org sages.org/publications/tavac/wats3d/

WATS3D - A SAGES Technology and Value Assessment Wide-area transepithelial sampling with computer-assisted 3-dimensional analysis (WATS) markedly improves detection of esophageal dysplasia and ...