The Analysis of WATS3D (Wide Area Transepithelial Sample Biopsy With 3-Dimensional Computer-Assisted Analysis) Increased Yield of Barrett's Esophagus and Esophageal Dysplasia
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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.
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. [ Time Frame: up to 18 years ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
patients with esophageal disease
Both males and females at least 18 years of age undergoing EGD to evaluate signs or symptoms suggestive of upper gastrointestinal disease.
Patients with known GERD undergoing a screening EGD with accompanying WATS3D biopsies and forceps biopsies.
Patients with known BE undergoing a surveillance EGD with accompanying WATS3D biopsies and forceps biopsies.
Patients with a known prior history (recent or remote) of dysplasia of either indefinite, low grade or high-grade, or intramucosal adenocarcinoma undergoing a surveillance EGD with accompanying WATS3D biopsies and forceps biopsies.
Patients who have undergone radiofrequency ablation orcryoablation who are undergoing surveillance EGD with accompanying WATS3D biopsies and forceps biopsies will be included in the study. The results of this group of patients will be analyzed separately from patients undergoing screening and surveillance who have not been ablated.
Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study.
Patients who on their initial evaluation have a visible highly suspicious lesion, such as a nodule or ulcer, (noted while undergoing endoscopy) that requires targeted biopsy will be excluded from the study.
Patients who do not undergo both Forceps Biopsy and WATS3D biopsy of the esophagus. Subsequent endoscopic evaluation may include forceps biopsies alone, WATS3D biopsies alone, both forceps and WATS3D biopsies, or no biopsies.
Patients with visible lesions that are either submucosal or covered with intact epithelium.