Clinical trial · Observational
The Evaluation of Patients With Esophageal and Foregut Disorders With WATS (Wide Area Transepithelial Sample With 3-Dimensional Computer-Assisted Analysis) vs. 4-Quadrant Forceps Biopsy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients scheduled to undergo routine upper endoscopy for foregut or esophageal symptoms or undergoing surveillance for Barrett's esophagus with no dysplasia or low-grade dysplasia are candidates for participation, but patients with known high-grade dysplasia or adenocarcinoma or with a history of prior endoscopic resection or ablation for these conditions are not candidates for participation. At endoscopy, all patients will be initially assessed for the presence of an endoscopic suspicious lesion using white light and if appropriate narrow band imaging or similar enhanced imaging techniques. All suspicious lesions undergo targeted biopsy first, and then either 4-Quadrant Random Forceps Biopsy or WATS biopsies of the GEJ and if present the columnar-lined esophagus based on the assigned randomization away from the area of targeted biopsies. A biopsy will be obtained from the antrum in each patient to assess for H. pylori infection and the presence of intestinal metaplasia.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
| Esophageal Diseases | — | UNRESOLVED | — |
| GERD | — | UNRESOLVED | — |
| Low Grade Esophageal Glandular Dysplasia | Low Grade Esophageal Glandular Intraepithelial Neoplasia | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- 4-Quadrant Random Forceps Biopsy
- description
- Random sampling within a quadrant of esophageal tissue using forceps.
- label
- WATS biopsies
- description
- Wide area transepithelial sampling with computer aided pathologic interpretation of tissue.
Primary outcomes (1)
- measure
- Yield of WATS biopsies compared to Forceps biopsies
- timeFrame
- 12 months
- description
- Intestinal metaplasia is a premalignant change in the normal epithelium lining the esophagus and gastroesophageal junction. It is evaluated on tissue samples from these areas by a pathologist under a microscope, who then determines if intestinal metaplasia is present or not. All specimens retrieved by upper endoscopy, whether by standard biopsy or by WATS, will be examined by a pathologist. The pathology reports will be reviewed and the frequency that intestinal metaplasia is found by standard biopsy vs WATS will be statistically compared.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Both males and females at least 18 years of age undergoing routine upper endoscopy to evaluate symptoms of esophageal or foregut disorders (reflux disease, BE, esophageal strictures, swallowing disorders, dyspepsia, hiatal hernias, motility issues, gastric issues). * Institutional Review Board (IRB)-approved consent must be signed by patients prior to participating in this study. Exclusion Criteria: * Patients who do not undergo either FB or WATS biopsy * Patients with inadequate WATS or FB specimens * Known history of high-grade dysplasia or adenocarcinoma * Prior history of endoscopic resection or ablation for Barrett's with high-grade dysplasia or adenocarcinoma
References
Publications (1)
- DERIVEDDeMeester S, Smith C, Severson P, Loveitt A, Jobe B, Woodworth P, Wilcox D, Dunst C; Hawaii Esophageal Course Study Group. Multicenter randomized controlled trial comparing forceps biopsy sampling with wide-area transepithelial sampling brush for detecting intestinal metaplasia and dysplasia during routine upper endoscopy. Gastrointest Endosc. 2022 Jun;95(6):1101-1110.e2. doi: 10.1016/j.gie.2021.11.044. Epub 2021 Dec 10. PMID 34902373