Recruiting

Narrow Band Imaging

Sponsor:

University of Southern California

Code:

NCT02197351

Conditions

Gastric Cancer

Gastric Metaplasia

Gastric Dysplasia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

White light biopsy

Protocolled

Narrow Band Imaging Guided Biopsy

Study Details

Brief summary:

It is thought that the development of cancer of the stomach follows a series of stages in which the lining becomes increasingly abnormal. Early detection of precursors of gastric cancer likely enable less invasive treatment.

The assessment of gastric mucosa using the endoscope is used to detect cancers and these precursor lesions. Narrow band imaging uses filtered light already built into modern endoscopoes to identify the early changes in the gastric lining.

The investigators' hypothesis is that narrow band imaging improves detection of precursor lesions and is a method amenable to international standardization.

The investigators will conduct a prospective trial in which standard random biopsy, white light guided biopsy, and narrow band imaging guided biopsy will be performed for each patient. The yield of the different methods for gastric cancer precursors will thus be compared.

Conditions

Gastric Cancer

Gastric Metaplasia

Gastric Dysplasia

Study ID

NCT02197351

Start date

Jul, 2014

Status verified date

Mar, 2023

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • presenting for upper endoscopy for gastric indications
  • gastric indications include upper abdominal pain dyspepsia abnormal gastric imaging iron deficiency anemia gastric ulcer management of GI blood loss without active bleeding reflux weight loss.

Exclusion Criteria:

  • Subjects who are incarcerated, younger than 18, or unable to give informed consent will be excluded.
  • Patients who have evidence of active gastrointestinal bleeding will be excluded
  • Patients taking anti-thrombotic agents including clopidogrel, ticlopidine, coumadin, heparin, enoxaparin, and direct II or Xa inhibitors
  • Patients with INR >1.5, platelet count <75,000

Study Design

Enrollment

220 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Gastric Symptoms

Patients with gastric symptoms including dyspepsia undergoing upper endoscopy will undergo white light biopsy narrow band imaging guided biopsy protocolled biopsy

Interventions

White light biopsy

Endoscopy with biopsies guided by high definition white light

Protocolled

Upper Endoscopy with Protocolled Biopsy (i.e. biopsy by predetermined guideline not influenced by white light or narrow band imaging findings)

Narrow Band Imaging Guided Biopsy

Upper Endoscopy with biopsy guided by narrow and imaging

Primary outcome measure

  • Detection of Intestinal Metaplasia or Dysplasia [ Time Frame: One Year ]

Central Contacts and Locations

Central contacts

James Buxabum, MD

323 409 5371jbuxbaum@usc.edu

Maria Trujillo

323 409 0939mit@usc.edu

Locations

Los Angeles County Hospital

Recruiting

Los Angeles, California, United States, 90033

Contacts

Maria Trujillo

323-409-6939mit@usc.edu

James Buxbaum, MD

323 409 5371jbuxbaum@usc.edu

More Information

Sponsor

University of Southern California

Last update posted

Mar 6, 2023

Last verified

Mar, 2023

Keywords

  • stomach neoplasms
  • narrow band imaging
  • gastroscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2023-03-06.