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

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.

Study Overview

• Status: Completed
• Conditions: Esophageal Diseases; GERD; Barrett Esophagus; Low Grade Esophageal Glandular Dysplasia

Detailed Description

Patients scheduled to undergo routine upper endoscopy for foregut or esophageal symptoms will be enrolled. Patients 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. Informed consent will be obtained from every patient prior to enrollment.

Patients will be randomized prior to starting the procedure. Each patient will receive a randomization code at the time of randomization. It is important that the randomization code be included in the Case Report Form submitted with each patient, and will represent the unique deidentified code for each patient's data for inclusion in the study database.

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.

Targeted forceps biopsies of any endoscopic suspicious area will be placed in a separate pathology bottle from those obtained from 4-Quadrant Random Forceps Biopsy and analyzed separately as well.

All the components needed to perform WATS biopsies are included in a kit with complete written instructions.

WATS specimens will be analyzed by CDx Diagnostics. Investigator will ship the WATS specimens to CDx Diagnostics in accordance with CDx's instructions. Forceps biopsies will be analyzed by institution's pathology department and the pathology department of each additional site participating in the Study per standard protocol.

The Investigator will determine appropriate follow-up of patients with and without IM or dysplasia detected by WATS or FB per standard individual and / or institution protocol.

Investigator and all investigators at the additional sites will supply the study coordinator with de-identified data for each specimen, such de-identified data including patient demographics, endoscopic findings, and results of the FB of GEJ, antrum plus / minus esophagus. Study Data will be maintained on a secure database by the study coordinator during the Term and for six years thereafter.

Biopsies with intestinal metaplasia or dysplasia may be reviewed by a central pathologist to confirm the original pathologic interpretation when there is a discrepancy between WATS and FB that is greater than 10%.

• Study Type: Observational
• Enrollment (Actual): 1032

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Eligible patients are those who undergo routine upper endoscopy while under sedation to evaluate foregut or esophageal symptoms.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
4-Quadrant Random Forceps Biopsy; Random sampling within a quadrant of esophageal tissue using forceps.
WATS biopsies; Wide area transepithelial sampling with computer aided pathologic interpretation of tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Yield of WATS biopsies compared to Forceps biopsies	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.	12 months

Collaborators and Investigators

• Sponsor: CDx Diagnostics
• Collaborators: Foundation for Surgical Innovation and Education

Publications and helpful links

General Publications

• DeMeester 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2017
• Primary Completion (ACTUAL): December 31, 2018
• Study Completion (ACTUAL): December 31, 2018

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: February 27, 2019
• First Posted (ACTUAL): March 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 1, 2019
• Last Update Submitted That Met QC Criteria: February 27, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Precancerous Conditions; Barrett Esophagus; Esophageal Diseases
• Other Study ID Numbers: CDx 810b

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No