Clinical trial NCT03008980: WATS3D for the Detection of Esophageal Dysplasia
Official title: Wide Area Transepithelial Sample Esophageal Biopsy Combined With Computer Assisted 3-Dimensional Analysis (WATS) for the Detection of Esophageal Dysplasia: A Prospective, Randomized, Tandem Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barrett Esophagus
Esophageal Dysplasia
Esophagus Adenocarcinoma
Lead sponsor: CDx Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: Rockford Gastroenterology Associates
name: Icahn School of Medicine at Mount Sinai
name: Temple University
name: University of Rochester
name: University of Kansas Medical Center
name: NYU Langone Health
First posted: 2017-01-04
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with known Barrett's Esophagus.

Brief summary: Patients will be recruited from participating institutions prior to planned routine care EGD with WATS3D brush samples and forceps biopsies. Eligibility will be reviewed and patients who are potentially eligible for the study will be approached regarding the study. If interested, participants will be consented and proceed with routine care EGD. The study coordinator or other research personnel will document information from the routine care endoscopy as part of this research study. Follow-up information collected will include WATS3D cytology and forceps biopsy pathology results from any routine care endoscopy performed during the course of participation in the study, any surgeries received and related to their condition, and any other care received as part of their condition. WATS3D samples will be sent to CDx Diagnostics for analysis.


Eligibility criteria: Inclusion Criteria:

* Patients age: ≥ 18 years
* Patients should have a history of Barrett's esophagus (with or without dysplasia of either indefinite, low grade or high-grade)
* Willingness to undergo both WATS and forceps biopsies while undergoing conventional EGD with sedation
* Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation
* Only patients who undergo both forceps biopsies and WATS of the esophagus will be included in this study

Exclusion criteria:

* Coagulopathy with an international normalized ratio above 2.0;
* Thrombocytopenia with platelet counts below 50,000
* History of prior esophageal ablation therapies, esophageal or gastric surgery
* Unresolved drug or alcohol dependency
* Pregnancy or planned pregnancy during the study period
* Patients found to have a BE length less than 1 cm or greater than 10 cm
* Patients with any visible lesions greater than 10 mm

Primary outcomes:
measure: Outcomes of patients undergoing WATS sampling. Specifically incremental yield for Barrett's Esophagus and Esophageal Dysplasia due to WATS sampling above that noted from routine forceps biopsies in various clinical settings.
timeFrame: up to 18 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Mike Smith
state: Pennsylvania
Study officials:
References:
citation: Vennalaganti PR, Kaul V, Wang KK, Falk GW, Shaheen NJ, Infantolino A, Johnson DA, Eisen G, Gerson LB, Smith MS, Iyer PG, Lightdale CJ, Schnoll-Sussman F, Gupta N, Gross SA, Abrams J, Haber GB, Chuttani R, Pleskow DK, Kothari S, Goldblum JR, Zhang Y, Sharma P. Increased detection of Barrett's esophagus-associated neoplasia using wide-area trans-epithelial sampling: a multicenter, prospective, randomized trial. Gastrointest Endosc. 2018 Feb;87(2):348-355. doi: 10.1016/j.gie.2017.07.039. Epub 2017 Jul 27.