Recruiting

Endoscopic TherapyWide-Area Transepithelial Sampling in Endoscopic Eradication Therapy for Barrett's Esophagus

Sponsor:

Northwestern University

Code:

NCT05056051

Conditions

Barrett Esophagus

Esophageal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

WATS-3D tissue sampling prior to forceps biopsies

WATS-3D tissue sampling following forceps biopsies

Study Details

Brief summary:

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.

Conditions

Barrett Esophagus

Esophageal Cancer

Study ID

NCT05056051

Start date

Oct 1, 2020

Status verified date

Apr, 2024

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

All patients aged 18+ diagnosed with Barrett's esophagus with confirmed histologic dysplasia or intra-mucosal cancer undergoing surveillance after EET
Patients who have achieved CE-IM on at least one surveillance endoscopy following EET
All subjects must have given signed, informed consent prior to registration in the study

Exclusion Criteria:

All patients who are unable or unwilling to give consent will not be included in the study
All patients deemed to have refractory BE despite EET
Patients who are pregnant, vulnerable populations such as prisoners, life expectancy < 1 year based on concurrent comorbidities, coagulopathy with INR > 1.5 that cannot be reversed, thrombocytopenia with platelets < 125,000 that cannot be corrected with blood products, unable to safely undergo elective endoscopy due to current comorbidities, and inability to pass standard endoscope will not be included in the study

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Post-EET Surveillance Group: WATS-3D samples followed by Forceps biopsies

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.

active comparator: Post-EET Surveillance Group: Forceps biopsies followed by WATS-3D samples

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.

Interventions

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

Primary outcome measure

To assess the additive diagnostic yield as assessed by proportion of patients with recurrence be use of WATS-3D [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Srinadh Komanduri, MD, MS

3126950484 skomandu@nm.org

Domenico AJ Farina, MD

3129144602 domenico.farina@northwestern.edu

Locations

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Srinadh Komanduri, MD, MS

312-695-4077 skomandu@nm.org

More Information

Sponsor

Northwestern University

Last update posted

Apr 24, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2024-04-24.