Novel Approach to Surveillance of Gastric Lesions

Early Phase 1

• Conditions: Atrophic Gastritis; Gastric Cancer; Intestinal Metaplasia of Gastric Mucosa; Gastric Dysplasia
• Interventions: Diagnostic Test: Mucosal Irrigation

• Registration Number: NCT04251403
• Lead Sponsor: New York Presbyterian Hospital

Brief Summary

This will be a pilot study investigating the feasibility of using pressurized irrigation of the stomach mucosa to obtain gastric aspirate cell samples for analysis and identification of premalignant lesions of the stomach.

Detailed Description

Gastric cancer is an important public health concern, accounting for 26,240 new cases in the United States (US) annually. Outcomes are poor, with 5-year survival of 31%, but improve when lesions are detected at early stages amenable to curative therapy. Research has shown that lesions such as atrophic gastritis and gastric intestinal metaplasia are precursors to more advanced lesions such as dysplasia and adenocarcinoma, thus providing a potential target for early intervention. Gastric cancer screening programs have decreased mortality in high-prevalence countries like Japan. However, providers in low-prevalence settings are less experienced at detecting precursor lesions endoscopically on visual inspection. This pilot study will investigate a novel approach to screening for precursor lesions and early detection of gastric cancer by utilizing pressurized irrigation of the gastric mucosa. The study will target patients with a known history of gastric precursor lesions (atrophic gastritis, intestinal metaplasia, history of dysplasia) who are presenting for routine surveillance endoscopy. Following routine endoscopic evaluation, the investigators will utilize the ERBEJET 2 device (ERBE USA Inc), which is commercially available for the treatment of mucosal lesions, to sample cells from the mucosal surface of the stomach. The aspirate will be collected for cytologic/pathologic assessment. The goal is that this technique will simplify testing for precursor lesions of gastric cancer, making screening more effective in regions of lower prevalence where providers are less experienced with visual identification of such lesions.

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-28
• Study First Submitted QC: 2020-01-30
• Last Update Submitted: 2020-01-30
• Study First Posted: 2020-01-31
• Last Update Posted: 2020-01-31
• Study Start: 2020-02
• Primary Completion: 2021-02
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Individuals with a known history of gastric precursor lesions (atrophic gastritis, intestinal metaplasia, history of dysplasia) who are presenting for routine surveillance endoscopy

Exclusion Criteria

• Personal history of gastric cancer
• Personal history of irritable bowel disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mucosal Irrigation	Mucosal Irrigation	Following routine endoscopic evaluation, investigators will utilize the ERBEJET 2 device (ERBE USA Inc), which is commercially available for the treatment of mucosal lesions, to sample cells from the mucosal surface of the stomach. The aspirate will be collected for cytologic/pathologic assessment.

Primary Outcome Measures

Name	Time	Method
Correlation of pathologic diagnosis from gastric aspirate compared with diagnosis from standard endoscopic inspection and biopsies.	Intra-procedural	Investigators will compare how the diagnosis determined from pathologic/cytologic analysis gastric aspirate samples will compare with diagnosis obtained from standard endoscopic inspection and biopsies. The diagnoses of interest will be normal mucosa, atrophic gastritis, intestinal metaplasia, dysplasia, or malignancy. This will be reported as the percentage of concordant diagnoses.