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

Recruiting at 4 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?

This trial examines a new method called WATS-3D (Wide-Area Transepithelial Sampling with 3-Dimensional Computer-Assisted Analysis) to enhance the detection of Barrett's esophagus, a condition that can lead to esophageal cancer if not detected early. The researchers aim to determine if WATS-3D can identify recurring Barrett's esophagus more effectively than current methods, enabling earlier treatment to prevent cancer. The trial includes two groups: one using WATS-3D before standard biopsies and another using it afterward. Individuals treated for Barrett's esophagus who have had a follow-up endoscopy showing no signs of the condition might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve early detection and prevention strategies for 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.

What prior data suggests that WATS-3D is safe for detecting Barrett's esophagus?

Research shows that WATS-3D tissue sampling is generally easy for patients to handle. Studies have found that using WATS-3D along with standard biopsy methods improves the detection of changes in Barrett's esophagus. This indicates that the technology works well and is safe to use with current methods. The tool uses a brush to collect cells from a larger area of the esophagus, helping doctors find issues that might be missed with traditional biopsies.

Studies have not reported any major side effects from using WATS-3D. Since this method is used during regular endoscopy procedures, which are usually safe, the risks of WATS-3D remain low. Therefore, it is expected to be a safe choice for those considering participation in clinical trials for detecting Barrett's esophagus. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the WATS-3D tissue sampling method for detecting Barrett's Esophagus because it offers a unique approach compared to the standard forceps biopsies. Unlike traditional methods, WATS-3D uses a wide-area transepithelial sampling technique that collects a broader and deeper tissue sample, potentially increasing the detection rate of dysplasia and early cancerous changes. By integrating this with high-definition imaging, WATS-3D aims to enhance histological analysis and improve early diagnosis accuracy. This could lead to better patient outcomes by catching issues that might be missed with conventional biopsy methods.

What evidence suggests that WATS-3D is effective for detecting Barrett's esophagus?

Research has shown that WATS-3D significantly improves the detection of Barrett's esophagus and abnormal cells in the esophagus that could lead to cancer. In this trial, participants will be divided into two groups: one will receive WATS-3D sampling followed by forceps biopsies, while the other will receive forceps biopsies followed by WATS-3D sampling. Studies indicate that using WATS-3D alongside regular biopsies detects more cases than traditional methods alone. This technology employs a special brush to collect samples from a larger area of the esophagus, helping to identify changes that might otherwise be missed. The American Foregut Society supports the use of WATS-3D, citing sufficient evidence to recommend it for diagnosing Barrett’s esophagus. Overall, WATS-3D is a promising tool for better and earlier detection of changes in the esophagus. ^{1 4 6 7 8}

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.

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

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

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

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 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]

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]

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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32578042/

Wide Area Transepithelial Sampling with Computer- ... Conclusions: Screening for BE in 60-year-old white male GERD patients is more cost-effective when WATS3D is used adjunctively to the Seattle ...

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

Wide Area Transepithelial Sampling with Computer ... Screening for BE in 60-year-old white male GERD patients is more cost-effective when WATS 3D is used adjunctively to the Seattle protocol than with the Seattle ...

3. 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.

4. americanforegutsociety.org americanforegutsociety.org/assets/docs/CDX-white-paper.pdf

Wide Area Transepithelial Sampling with Computer ... The American. Foregut Society (AFS) Board has concluded that there are sufficient data to support the routine use of WATS3D technology in the diagnosis and ...

5. cdxdiagnostics.com cdxdiagnostics.com/news/wats3d-revolutionizes-barretts-esophagus-management

WATS3D Revolutionizes Barrett's Esophagus Management ... WATS 3D has been found to significantly increase the detection rate of both Barrett's esophagus and esophageal dysplasia.

6. link.springer.com link.springer.com/article/10.1007/s10620-020-06412-1

Wide Area Transepithelial Sampling with Computer- ... WATS3D uses an abrasive brush, deployed during endoscopy, which is designed to sample a much larger and circumferential mucosal area of the ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36150646/

Wide-area transepithelial sampling with computer-assisted ... Wide-area transepithelial sampling (WATS) may increase detection of high grade dysplasia (HGD) and esophageal adenocarcinoma (EAC).

8. 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 ...