WATS-3D Tissue Sampling for Barrett's Esophagus Detection

Recruiting at 3 trial locations

Overseen By Srinadh Komanduri, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Pregnancy, Refractory BE, Coagulopathy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 24 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Esophageal cancer is a deadly disease that is becoming increasingly common in the United States. Barrett's esophagus (BE) is a pre-cancerous state that can develop into esophageal cancer, but is highly treatable. Progression of BE to esophageal cancer is still common due to missed diagnosis of Barrett's esophagus recurrence following treatment. Wide-Area Trans-Epithelial Sampling (WATS-3D) is a new technology that uses brush sampling to examine larger areas of the esophagus as compared to conventional biopsies. Preliminary studies show improved detection of cancerous changes in Barrett's esophagus surveillance. The investigators hope to see if the addition of WATS-3D increases the rate of detection of recurrent BE following treatment, which is of the utmost importance since it would allow for earlier re-treatment of disease and ultimately allow for prevention of progression to esophageal cancer.

Do I need to stop my current medications for the trial?

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

How does the WATS-3D treatment for Barrett's Esophagus differ from other treatments?

WATS-3D is unique because it uses a brush biopsy device to extensively sample the esophagus and employs computer-assisted 3D analysis to detect abnormal cells, which increases the detection rate of Barrett's Esophagus compared to traditional forceps biopsies. ^{1 2 3 4 5}

What data supports the effectiveness of the WATS-3D treatment for Barrett's Esophagus Detection?

Research shows that using WATS-3D along with standard biopsies significantly improves the detection of Barrett's Esophagus and related abnormal cell growth. In a large study, WATS-3D found many more cases of these conditions than biopsies alone, increasing detection rates by over 150% for Barrett's Esophagus and over 240% for abnormal cell growth. ^{1 2 4 5 6}

Who Is on the Research Team?

Srinadh Komanduri

Principal Investigator

Feinberg School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Barrett's esophagus who've had previous treatment and are under surveillance. They must have shown some healing in a past check-up and be able to give informed consent. Pregnant individuals, prisoners, those with a life expectancy less than a year, severe blood platelet or clotting issues, or an inability to undergo endoscopy safely are excluded.

Inclusion Criteria

I have shown improvement in my esophagus condition after treatment.

I am 18 or older with Barrett's esophagus and have had early cancer or precancerous changes.

All subjects must have given signed, informed consent prior to registration in the study

Exclusion Criteria

Vulnerable populations such as prisoners

Patients who are pregnant

My Barrett's esophagus hasn't improved with standard treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo endoscopic eradication therapy (EET) and subsequent post-EET surveillance with WATS-3D and forceps biopsies

24 months

Multiple visits (in-person) for endoscopy and sampling

Follow-up

Participants are monitored for recurrence of intestinal metaplasia and dysplasia after treatment

3 years

Regular follow-up visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• WATS-3D tissue sampling following forceps biopsies
• WATS-3D tissue sampling prior to forceps biopsies

Trial Overview The study tests if using WATS-3D tissue sampling before or after standard biopsies improves detection of recurrent Barrett's esophagus after treatment. This could lead to earlier re-treatment and prevention of progression to esophageal cancer.

How Is the Trial Designed?

Group I: Post-EET Surveillance Group: WATS-3D samples followed by Forceps biopsies Active Control 1 Intervention

Sampling will occur with WATS-3D followed by forceps biopsies. For each patient, resection samples will be identified by the endoscopy method used to locate the sample as either HD-WLE/NBI or WATS-3D. For each method of detection, the highest grade of histology for each patient will be assigned based on the identified samples. Dysplasia detected on random biopsies will be attributed HD-WLE/NBI given it is part of the standard of care.

Group II: Post-EET Surveillance Group: Forceps biopsies followed by WATS-3D samples Active Control 1 Intervention

Sampling will occur with forceps biopsies followed by WATS-3D. For each patient, resection samples will be identified by the endoscopy method used to locate the sample as either HD-WLE/NBI or WATS-3D. For each method of detection, the highest grade of histology for each patient will be assigned based on the identified samples. Dysplasia detected on random biopsies will be attributed HD-WLE/NBI given it is part of the standard of care.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

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 8471 patients, the use of WATS-3D alongside traditional forceps biopsies significantly increased the diagnostic yield for intestinal metaplasia (IM) by 47.6% and for dysplasia by 139%, demonstrating its efficacy in detecting these conditions in Barrett's esophagus.

The effectiveness of WATS-3D varied with segment length; it was particularly beneficial for detecting IM in short-segment Barrett's esophagus, while it showed greater effectiveness for dysplasia detection in long-segment cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefit of adjunctive wide-area transepithelial sampling with 3-dimensional computer-assisted analysis plus forceps biopsy based on Barrett's esophagus segment length. Trindade, AJ., Odze, RD., Smith, MS., et al.[2023]

In a study of 108 patients, the WATS3D technique detected 21 additional cases of Barrett's esophagus (BE) that were missed by traditional forceps biopsies (FB), increasing the detection rate from 57.4% to 76%.

The use of WATS3D alongside FB improved the diagnostic yield for BE without increasing complications, suggesting it is a safe and effective enhancement to standard biopsy methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

WATS3D versus forceps biopsy in screening for Barrett's esophagus: experience in community endoscopy centers. Agha, YH., Srinivasan, S., Hyder, J., et al.[2022]

In a study involving 160 patients with Barrett's esophagus, the addition of wide-area transepithelial sampling (WATS) to standard biopsy sampling significantly increased the detection rate of high-grade dysplasia and esophageal adenocarcinoma (HGD/EAC) by 14.4%.

WATS was found to be effective in identifying cases that were previously classified as nondysplastic or low-grade dysplasia, and it only added an average of 4.5 minutes to the procedure time, making it a practical enhancement to existing diagnostic methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased detection of Barrett's esophagus-associated neoplasia using wide-area trans-epithelial sampling: a multicenter, prospective, randomized trial. Vennalaganti, PR., Kaul, V., Wang, KK., et al.[2019]

In a study involving 12,899 patients, the use of wide-area transepithelial sampling (WATS) alongside traditional forceps biopsy (FB) significantly improved the detection of esophageal dysplasia (ED), increasing the detection rate by 242% and identifying 213 additional cases that FB missed.

WATS also enhanced the detection of Barrett's esophagus (BE), with an absolute increase of 19.9% in cases identified, raising the detection rate from 13.1% to 33%, demonstrating that WATS is a valuable adjunct to FB in screening and surveillance for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wide-area transepithelial sampling with computer-assisted 3-dimensional analysis (WATS) markedly improves detection of esophageal dysplasia and Barrett's esophagus: analysis from a prospective multicenter community-based study. Smith, MS., Ikonomi, E., Bhuta, R., et al.[2020]

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. 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]

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

Benefit of adjunctive wide-area transepithelial sampling with 3-dimensional computer-assisted analysis plus forceps biopsy based on Barrett's esophagus segment length. [2023]

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

WATS3D versus forceps biopsy in screening for Barrett's esophagus: experience in community endoscopy centers. [2022]

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

Increased detection of Barrett's esophagus-associated neoplasia using wide-area trans-epithelial sampling: a multicenter, prospective, randomized trial. [2019]

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

Wide-area transepithelial sampling with computer-assisted 3-dimensional analysis (WATS) markedly improves detection of esophageal dysplasia and Barrett's esophagus: analysis from a prospective multicenter community-based study. [2020]

6. 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]