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

NCT03859557 | Completed

• 1 other identifier: CDx 810b
• Study Type: observational
• Target: 1,032
• Locations: 1 country
• Sites: 1

Brief Summary

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

GERD; Barrett Esophagus; Low Grade Esophageal Glandular Dysplasia; Esophageal Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CDx Diagnostics: lead
• Foundation for Surgical Innovation and Education: collaborator

Study Sites (1)

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Related Publications (1)

• 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.

  PMID: 34902373 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Barrett Esophagus; Esophageal Diseases

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Gastrointestinal Diseases; Digestive System Diseases; Precancerous Conditions; Neoplasms

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, President and Executive Director The Foundation for Research and Education in Esophageal and Foregut Disease

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: March 1, 2019
• Study Start: October 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 1, 2019

Record last verified: 2019-02

Locations

US (1)