An interventional study of WATS-3D tissue sampling prior to forceps biopsies and WATS-3D tissue sampling following forceps biopsies in Barrett Esophagus and Esophageal Cancer, sponsored by Northwestern University. Status unknown at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-24.
Sponsored by Northwestern University · Not applicable, Interventional, and Diagnostic
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.
Barrett's esophagus (BE) affects 5-15% of all patients with gastroesophageal reflux disease and approximately 1-2% of the entire population. The stepwise progression of BE from intestinal metaplasia (IM) to dysplasia can ultimately lead to esophageal adenocarcinoma (EAC). There are over 15,000 cases of EAC diagnosed in the United States each year. Regardless of stage of disease at time of diagnosis, the 5-year survival for EAC is an abysmal 19%. Endoscopic eradication therapy (EET) has been shown to be very effective in preventing progression of dysplastic BE to EAC with rates of complete eradication of intestinal metaplasia (CE-IM) > 90%. This is of paramount importance given the poor outcomes associated with the development of EAC.
Despite high success rates in achieving CE-IM, recent studies show that the recurrence of IM following CE-IM occurs with annual incidence of 8-10% and a 2-3% dysplasia rate per patient year of follow-up. The current paradigm of endoscopic surveillance following CE-IM focuses on random biopsies, which has raised concerns about sampling error and missed recurrence of IM and dysplasia leading to increased risk of interval development of EAC. New technologies, such as Wide-Area Trans-Epithelial Sampling (WATS-3D; CDx Diagnostics, Suffern, NY) have been studied to improve detection of dysplasia in BE. WATS-3D involves abrasive brush sampling of the esophagus that is then processed by a validated computer imaging system and subsequently reviewed by pathologist. Prior studies have shown increased dysplasia detection in routine BE surveillance with WATS-3D over standard biopsies, however there are no published data as to the additive value of WATS-3D for detection of recurrence of disease after endoscopic therapy.
Problem Statement:
Despite high success rates of successful eradication of BE with EET, recurrence rates are still high. Current Seattle Protocol biopsies for Post-EET surveillance is time-consuming, difficult to reproduce, and often misses IM recurrence putting patients at increased risk of developing EAC.
Hypothesis and Specific Aims:
The investigators hypothesize that the addition of WATS-3D to standard four-quadrant biopsies driven by HD-WLE and Narrow Band Imaging (NBI) will increase the rate of detection of recurrence of IM and dysplasia in patients who have undergone EET. To that end, increased recurrent IM detection will allow for proper choice of repeat EET and decreased progression to EAC. The specific aims:
The proposed study will be a prospective multi-center design over 24 months. The participating centers will include Northwestern University, Washington University in St. Louis, University of Colorado and University of California, Los Angeles.
316 studies on the registry are indexed under Barrett Esophagus; 62 are open to participants now.
This study's planned enrollment of 200 is above the median of 61 across 190 interventional studies indexed under Barrett Esophagus.
Browse Barrett Esophagus studies →Northwestern University is the lead sponsor of 1,420 studies on the registry; 199 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 75 (73%) have results posted.
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Exclusion Criteria:
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.
Device: WATS-3D tissue sampling prior to forceps biopsies
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.
Device: WATS-3D tissue sampling following forceps biopsies
WATS-3D is a brush-based tissue sampling technique. Abrasive brush sampling of large areas of the esophagus pick up cells to obtain trans-epithelial specimens. This technique samples much larger tissue areas than standard forceps biopsies. Analysis is then done by proprietary neural-network based computer scanning and molecular diagnostics to identify abnormal cells.
WATS-3D is a brush-based tissue sampling technique. Abrasive brush sampling of large areas of the esophagus pick up cells to obtain trans-epithelial specimens. This technique samples much larger tissue areas than standard forceps biopsies. Analysis is then done by proprietary neural-network based computer scanning and molecular diagnostics to identify abnormal cells. This will be done after forceps biopsies in this arm.
To assess the additive diagnostic yield as assessed by proportion of patients with recurrence be use of WATS-3D
To assess the additive diagnostic yield of WATS-3D sampling beyond that of standard biopsies for detection of IM or dysplasia (recurrence) in patients who have undergone EET for BE-related neoplasia. The rates of recurrence as determined by the proportion of patients (percentage) deemed to have recurrence of BE on tissue sampling will be compared between samples obtained by WATS-3D vs forceps biopsies.
Time frame: 2 years
To assess if there is a difference in diagnostic yield of WATS-3D based on CE-IM definition between one and two or more endoscopies
To assess the difference in additive diagnostic yield of WATS-3D sampling beyond that of standard biopsies between CE-IM, the proportion of patients with recurrence will be compared based if CE-IM was based on a single exam without IM vs. two or more successive exams without IM.
Time frame: 3 years
To assess if the order by which tissue is sampled affects the diagnostic yield of WATS-3D by comparing the proportion of patients with recurrence between groups.
It is unclear if there is any impact of order of tissue acquisition techniques on detection of recurrent IM or dysplasia. By randomizing patients to either WATS-3D first followed by forceps biopsies vs forceps biopsies followed by WATS-3D, the proportion of patients with recurrence will be compared to see if the order of sampling affects the proportion of patients found to have recurrent BE.
Time frame: 3 years
Started Oct 2020 (actual). Primary completion is estimated for Jun 2025, 56 months after the start.
Of 66 non-industry interventional studies with no phase under Barrett Esophagus, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 108. This study's planned 56 months is close to that.
Counting every sponsor, half of 77 studies reached it within 52 months; a quarter within 23 and three quarters within 102.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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