Additive Value of Wide-Area Transepithelial Sampling (WATS3D) in Detection of Recurrence of Intestinal Metaplasia Following Endoscopic Eradication Therapy (EET) for Barrett's Esophagus-Related Neoplasia

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
United States
California
University of California, LA
Not yet recruiting
Los Angeles
Colorado
University of Colorado
Not yet recruiting
Aurora
Illinois
Northwestern Memorial Hospital
Recruiting
Chicago
Missouri
Washington University in St. Louis, Barnes Jewish Hospital
Not yet recruiting
Saint Louis
Contact Information
Primary
Srinadh Komanduri, MD, MS
skomandu@nm.org
3126950484
Backup
Domenico AJ Farina, MD
domenico.farina@northwestern.edu
3129144602
Time Frame
Start Date: October 1, 2020
Estimated Completion Date: June 30, 2024
Participants
Target number of participants: 200
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Washington University School of Medicine, University of California, Los Angeles, University of Colorado, Denver
Leads: Northwestern University

This content was sourced from clinicaltrials.gov

Similar Clinical Trials