WATS-3D Tissue Sampling for Barrett's Esophagus Detection
Recruiting in Palo Alto (17 mi)
+3 other locations
Overseen bySrinadh Komanduri
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Northwestern University
Disqualifiers: Pregnancy, Refractory BE, Coagulopathy, others
No Placebo Group
Trial Summary
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.
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.
12345How 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.
12346Eligibility Criteria
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.
+6 more
Trial Timeline
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)
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
University of California, LALos Angeles, CA
University of ColoradoAurora, CO
Northwestern Memorial HospitalChicago, IL
Washington University in St. Louis, Barnes Jewish HospitalSaint Louis, MO
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Who Is Running the Clinical Trial?
Northwestern UniversityLead Sponsor
Washington University School of MedicineCollaborator
University of California, Los AngelesCollaborator
University of Colorado, DenverCollaborator
References
Wide Area Transepithelial Sampling with Computer-Assisted Analysis (WATS3D) Is Cost-Effective in Barrett's Esophagus Screening. [2021]Label="BACKGROUND">Wide area transepithelial sampling with three-dimensional computer-assisted analysis (WATS3D) is an adjunct to the standard random 4-quadrant forceps biopsies (FB, "Seattle protocol") that significantly increases the detection of Barrett's esophagus (BE) and associated neoplasia in patients undergoing screening or surveillance.
Benefit of adjunctive wide-area transepithelial sampling with 3-dimensional computer-assisted analysis plus forceps biopsy based on Barrett's esophagus segment length. [2023]Wide-area transepithelial sampling with 3-dimensional computer-assisted analysis (WATS-3D) has been shown to increase the diagnostic yield of intestinal metaplasia (IM) and dysplasia within a segment of suspected or known Barrett's esophagus (BE) when used as an adjunct to forceps biopsies. Few data are available regarding how segment length affects WATS-3D yield. The purpose of this study was to evaluate adjunctive WATS-3D use in patients with varying lengths of BE.
WATS3D versus forceps biopsy in screening for Barrett's esophagus: experience in community endoscopy centers. [2022]Label="BACKGROUND" NlmCategory="BACKGROUND">Barrett's esophagus (BE) is a premalignant condition diagnosed using systematic 4-quadrant forceps biopsies (FB) during endoscopy. This method is fraught with errors due to the randomness of sampling and variability among operators. Wide-area transepithelial sampling with 3-dimensional computer-assisted analysis (WATS3D) is an emerging technique used to collect esophageal samples. The aim of this study was to evaluate WATS3D as a diagnostic tool for detecting BE in addition to FB, compared to FB alone.
Increased detection of Barrett's esophagus-associated neoplasia using wide-area trans-epithelial sampling: a multicenter, prospective, randomized trial. [2019]Wide-area transepithelial sampling (WATS) with computer-assisted 3-dimensional analysis is a sampling technique that combines abrasive brushing of the Barrett's esophagus (BE) mucosa followed by neural network analysis to highlight abnormal-appearing cells.
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]The 4-quadrant forceps biopsy (FB) protocol for identifying Barrett's esophagus (BE) and esophageal dysplasia (ED) suffers from poor sensitivity due to significant sampling error. We investigated the benefit of wide-area transepithelial sampling with 3-dimensional computer-assisted analysis (WATS) used adjunctively to the combination of random and targeted FB in the detection of ED, and as a secondary outcome, BE. In this multicenter prospective trial, community endoscopists at 21 sites utilized WATS as an adjunct to both targeted and random FB in patients undergoing BE screening and surveillance. Investigators alternated taking FB and WATS samples first. WATS specimens were analyzed at CDx Diagnostics (Suffern, NY) while FB samples were analyzed by each site's regular pathologists. Data were de-identified and then aggregated for analysis. Of 12,899 patients enrolled, FB identified 88 cases of ED, and WATS detected an additional 213 cases missed by FB. These 213 cases represented an absolute increase of 1.65%, raising the yield from 0.68% to 2.33%. Adding WATS to FB increased the overall detection of ED by 242% (95% CI: 191%-315%). Fewer than 61 patients needed to be tested with WATS to identify an additional case of ED. The combination of random and targeted FB identified 1,684 cases of BE, and WATS detected an additional 2,570 BE cases. The absolute incremental yield of adding WATS to FB is 19.9%, increasing the rate of detection from 13.1% to 33%. Adding WATS to FB increased the overall detection of BE by 153% (95% CI: 144-162%). The number needed to test with WATS in order to detect an additional case of BE was 5. Whether FB or WATS was done first did not impact the results. In this study, comprised of the largest series of patients evaluated with WATS, adjunctive use of the technique with targeted and random FB markedly improved the detection of both ED and BE. These results underscore the shortcomings of FB in detecting BE-associated neoplasia, which can potentially impact the management and clinical outcomes of these patients.
Role of Wide-Area Transepithelial Sampling With 3D Computer-Assisted Analysis in the Diagnosis and Management of Barrett's Esophagus. [2023]Barrett's esophagus (BE) is a premalignant condition in which cancer prevention is performed by endoscopic surveillance combined with Seattle protocol mucosal biopsies. The Seattle protocol has significant limitations, including a high rate of sampling error due to the focality of dysplasia/carcinoma, low endoscopist adherence to the protocol, and a high degree of variability in pathologic interpretation. These factors all contribute to a high incidence of cancers missed within 1 year of surveillance endoscopy. Wide-area transepithelial sampling with computer-assisted three-dimensional analysis (WATS3D) is a relatively new technique that minimizes sampling error by using a brush biopsy device that extensively samples "at risk" mucosa and helps pathologists diagnose dysplasia/neoplasia by generating three-dimensional images of whole crypts using a neural network-based software program. Several large prospective trials (involving both academic and community practices) have shown significantly increased rates of detection of dysplasia and intestinal metaplasia in both screening and surveillance in patients with BE when used as an adjunct to Seattle protocol-based forceps biopsies. The WATS3D diagnostic platform was included in the most recent American Society for Gastrointestinal Endoscopy Barrett's guideline as an adjunct to forceps biopsies (conditional recommendation and low quality of evidence). This review summarizes the scientific and pathologic basis of WATS3D technology, its potential impact on BE surveillance and management, and its limitations and future directions.