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

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

Research Team

Sachin Wani, MD

Principal Investigator

University of Colorado, Denver

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.

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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

SAGES TAVAC safety and efficacy analysis WATS3D (CDx Diagnostics, Suffern, NY). [2021]