353 Multi-Center Randomized Trial Comparing Standard Forceps Biopsies to Wide-Area Transepithelial Sampling Brush for Finding Intestinal Metaplasia and Dysplasia in the Esophagus and Gastroesophageal Junction

Abstract

INTRODUCTION: Intestinal metaplasia (IM) in the esophagus is a potentially pre-malignant mucosal change. The aim of this study was to compare the frequency of IM detection during upper endoscopy by biopsy forceps versus wide-area transepithelial sampling (WATS) brush. METHODS: Patients presenting for upper endoscopy for foregut symptoms or Barrett’s surveillance were prospectively enrolled and randomized to either biopsies or WATS brush from October1, 2017 to December 31, 2018. Patients with a history of malignancy were excluded. This study was IRB approved and funded by CDx Diagnositics. RESULTS: There were 1002 patients enrolled at 9 centers. Patient demographics and indications for endoscopy are shown in Table 1. A total of 509 patients had biopsies and 493 had WATS. A columnar-lined esophagus (CLE) of any length was seen in 282 patients, while in 720 patients there was no CLE and the biopsy or WATS was from a normal or irregular appearing gastroesophageal junction (GEJ). The median length of CLE when present was 3 cm. The overall frequency of finding IM by biopsy was 19.45% and by WATS 22.72%, P = 0.2. Table 2 shows the frequency of finding IM in the 817 patients that had upper endoscopy with no prior history of IM, compared to the frequency of finding IM in patients undergoing endoscopy for Barrett’s surveillance or follow-up after ablation (n = 185). In patients without a prior history of IM, biopsy and WATS found IM with similar frequency overall, but WATS found significantly more IM in patients with any endoscopically visible length of CLE. Biopsy found one cancer, and low-grade dysplasia was found in one patient each with biopsy and WATS. In the 185 patients that had their endoscopy for follow-up of Barrett’s or ablation there was no difference in the frequency of IM detection for biopsy vs WATS, and was similar in patients with < 3 cm CLE and in those with ≥ 3 cm CLE. Dysplasia or cancer was found in 5 patients in this group, 2 by WATS and 3 by biopsy. CONCLUSION/DISCUSSION: Both biopsy and WATS detect a similar frequency of IM overall; however, WATS was over twice as likely as biopsies to find IM in patients without a history of IM who had a CLE on endoscopy. In patients undergoing surveillance for Barrett’s or follow-up after ablation both WATS and biopsy showed IM and dysplasia with similar frequency. These findings suggest that WATS can be used instead of biopsies of the GEJ and esophagus with similar or improved efficacy at detecting IM and dysplasia.