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Novel Approach to Surveillance of Gastric Lesions

NCT ID: NCT04251403

Last Updated: 2020-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-29

Study Completion Date

2021-02-28

Brief Summary

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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

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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.

Conditions

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Intestinal Metaplasia of Gastric Mucosa Gastric Dysplasia Gastric Cancer Atrophic Gastritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a pilot feasibility study. High-risk individuals with known history of gastric precursor lesions (atrophic gastritis, intestinal metaplasia, dysplasia) who are presenting for routine surveillance endoscopy will undergo mucosal irrigation and collection of gastric aspirate for analysis, in addition to standard of care (visual inspection on endoscopy).
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mucosal Irrigation

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New York Presbyterian Hospital

OTHER

Sponsor Role lead

Responsible Party

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Monika Laszkowska

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charles Lightdale, MD

Role: PRINCIPAL_INVESTIGATOR

New York Presbyterian - Columbia University Medical Center

Central Contacts

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Monika Laszkowska, MD

Role: CONTACT

Phone: 9179747218

Email: [email protected]

Charles Lightdale, MD

Role: CONTACT

Phone: (212) 305-3423

Email: [email protected]

References

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Hamashima C. Current issues and future perspectives of gastric cancer screening. World J Gastroenterol. 2014 Oct 14;20(38):13767-74. doi: 10.3748/wjg.v20.i38.13767.

Reference Type BACKGROUND
PMID: 25320514 (View on PubMed)

Gupta S, Li D, El Serag HB, Davitkov P, Altayar O, Sultan S, Falck-Ytter Y, Mustafa RA. AGA Clinical Practice Guidelines on Management of Gastric Intestinal Metaplasia. Gastroenterology. 2020 Feb;158(3):693-702. doi: 10.1053/j.gastro.2019.12.003. Epub 2019 Dec 6. No abstract available.

Reference Type BACKGROUND
PMID: 31816298 (View on PubMed)

Kim GH, Liang PS, Bang SJ, Hwang JH. Screening and surveillance for gastric cancer in the United States: Is it needed? Gastrointest Endosc. 2016 Jul;84(1):18-28. doi: 10.1016/j.gie.2016.02.028. Epub 2016 Mar 3.

Reference Type BACKGROUND
PMID: 26940296 (View on PubMed)

BASTOS AL, MADEIRA F. A SIMPLE DEVICE FOR EXFOLIATIVE CYTOLOGY OF THE STOMACH. Gut. 1964 Apr;5(2):192-3. doi: 10.1136/gut.5.2.192. No abstract available.

Reference Type BACKGROUND
PMID: 14159412 (View on PubMed)

Other Identifiers

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IRB-AAAS8330

Identifier Type: -

Identifier Source: org_study_id