200 Participants Needed

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

Recruiting at 3 trial locations
DA
SK
Overseen BySrinadh Komanduri, MD, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.12456

Who Is on the Research Team?

SK

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.
See 6 more

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?
2Treatment groups
Active Control
Group I: Post-EET Surveillance Group: WATS-3D samples followed by Forceps biopsiesActive Control1 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 samplesActive Control1 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.

Find a Clinic Near You

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

Citations

Wide Area Transepithelial Sampling with Computer-Assisted Analysis (WATS3D) Is Cost-Effective in Barrett's Esophagus Screening. [2021]
Benefit of adjunctive wide-area transepithelial sampling with 3-dimensional computer-assisted analysis plus forceps biopsy based on Barrett's esophagus segment length. [2023]
WATS3D versus forceps biopsy in screening for Barrett's esophagus: experience in community endoscopy centers. [2022]
Increased detection of Barrett's esophagus-associated neoplasia using wide-area trans-epithelial sampling: a multicenter, prospective, randomized trial. [2019]
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]
Role of Wide-Area Transepithelial Sampling With 3D Computer-Assisted Analysis in the Diagnosis and Management of Barrett's Esophagus. [2023]
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