New sampling technique for detecting Barrett's esophagus recurrence

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

This study is testing a new tissue sampling method to see if it can better detect the return of Barrett's esophagus in adults who have had treatment to get rid of it.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Northwestern University (Academic / other)
• Locations: 4 sites (Los Angeles, California and 3 other locations)
• Trial ID: NCT05056051 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of Wide-Area Trans-Epithelial Sampling (WATS-3D) in improving the detection of recurrent Barrett's esophagus (BE) after endoscopic eradication therapy (EET). The study aims to compare the results of WATS-3D tissue sampling with traditional forceps biopsies to determine if the new method can reduce missed diagnoses of dysplasia and prevent progression to esophageal cancer. Participants will include adults diagnosed with BE who have achieved complete eradication of intestinal metaplasia. The trial will be conducted at multiple leading medical institutions across the United States.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with Barrett's esophagus who have confirmed dysplasia or intra-mucosal cancer and have achieved complete eradication of intestinal metaplasia.

Not a fit: Patients who are unable to provide consent, have refractory Barrett's esophagus, or have significant comorbidities that prevent safe participation will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier detection and treatment of Barrett's esophagus recurrence, potentially preventing the progression to esophageal cancer.

How similar studies have performed: Preliminary studies have shown that similar approaches using WATS-3D technology have improved detection rates in Barrett's esophagus surveillance.

Eligibility criteria

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

Where this trial is running

Los Angeles, California and 3 other locations

• University of California, LA — Los Angeles, California, United States (Not_yet_recruiting)
• University of Colorado — Aurora, Colorado, United States (Not_yet_recruiting)
• Northwestern Memorial Hospital — Chicago, Illinois, United States (Recruiting)
• Washington University in St. Louis, Barnes Jewish Hospital — Saint Louis, Missouri, United States (Not_yet_recruiting)

Study contacts

• Principal investigator: Srinadh Komanduri — Feinberg School of Medicine
• Study coordinator: Srinadh Komanduri, MD, MS

Conditions Barrett Esophagus; Esophageal Cancer