Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Narrow Band Imaging for Gastric Neoplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02197351
Recruitment Status : Recruiting
First Posted : July 22, 2014
Last Update Posted : June 15, 2022
Sponsor:
Collaborator:
Universidade do Porto
Information provided by (Responsible Party):
James Buxbaum, University of Southern California

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.


Condition or disease Intervention/treatment Phase
Gastric Cancer Gastric Metaplasia Gastric Dysplasia Procedure: White light biopsy Procedure: Protocolled Procedure: Narrow Band Imaging Guided Biopsy Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Prospective Controlled Trial of Narrow Band Imaging for Detection of Gastric Cancer Precursors
Study Start Date : July 2014
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gastric Symptoms
Patients with gastric symptoms including dyspepsia undergoing upper endoscopy will undergo white light biopsy narrow band imaging guided biopsy protocolled biopsy
Procedure: White light biopsy
Endoscopy with biopsies guided by high definition white light

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

Procedure: Narrow Band Imaging Guided Biopsy
Upper Endoscopy with biopsy guided by narrow and imaging




Primary Outcome Measures :
  1. Detection of Intestinal Metaplasia or Dysplasia [ Time Frame: One Year ]
    Confirmation of intestinal metaplasia in stomach per patient by each method-NBI versus white light-versus random


Secondary Outcome Measures :
  1. Number of Regions with Intestinal Metaplasia [ Time Frame: 1 year ]
    Number of Region with Intestinal Metaplasia detected in the stomach (total not per patient) detected by each method-NBI versus white light-versus random

  2. Number of regions with dysplasia [ Time Frame: one year ]
    Number of regions with dysplasia detected in the stomach (total not per patient) detected by each method-NBI versus white light-versus random

  3. Biopsies driven by method [ Time Frame: One year ]
    Number of biopsies driven by each method. Number driven by each method-NBI versus white light-versus random will be compared.

  4. Helicobacter pyrlori detection [ Time Frame: One year ]
    Detection ofHelicobacter pylori by method



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02197351


Contacts
Layout table for location contacts
Contact: James Buxabum, MD 323 409 5371 jbuxbaum@usc.edu
Contact: Maria Trujillo 323 409 0939 mit@usc.edu

Locations
Layout table for location information
United States, California
Los Angeles County Hospital Recruiting
Los Angeles, California, United States, 90033
Contact: Maria Trujillo    323-409-6939    mit@usc.edu   
Contact: James Buxbaum, MD    323 409 5371    jbuxbaum@usc.edu   
Portugal
Department of Gastroenterology Portuguese Oncology Institute of Porto Not yet recruiting
Porto, Portugal
Contact: Mario Dinis-Ribeiro, MD    +351-22-5084055    mario@med.up.pt   
Contact: Diogo Dias da Silva, MD       diassilva.diogo@gmail.com   
Principal Investigator: Mario Dinis-Ribeiro, MD         
Sub-Investigator: Diogo Dias da Silva, MD         
Sponsors and Collaborators
University of Southern California
Universidade do Porto
Investigators
Layout table for investigator information
Principal Investigator: James Buxbaum, MD University of Southern California
Publications:
Dinis-Ribeiro M, Areia M, de Vries AC, Marcos-Pinto R, Monteiro-Soares M, O'Connor A, Pereira C, Pimentel-Nunes P, Correia R, Ensari A, Dumonceau JM, Machado JC, Macedo G, Malfertheiner P, Matysiak-Budnik T, Megraud F, Miki K, O'Morain C, Peek RM, Ponchon T, Ristimaki A, Rembacken B, Carneiro F, Kuipers EJ; European Society of Gastrointestinal Endoscopy; European Helicobacter Study Group; European Society of Pathology; Sociedade Portuguesa de Endoscopia Digestiva. Management of precancerous conditions and lesions in the stomach (MAPS): guideline from the European Society of Gastrointestinal Endoscopy (ESGE), European Helicobacter Study Group (EHSG), European Society of Pathology (ESP), and the Sociedade Portuguesa de Endoscopia Digestiva (SPED). Endoscopy. 2012 Jan;44(1):74-94. doi: 10.1055/s-0031-1291491. Epub 2011 Dec 23.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: James Buxbaum, Assistant Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT02197351    
Other Study ID Numbers: HS-14-00418
First Posted: July 22, 2014    Key Record Dates
Last Update Posted: June 15, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by James Buxbaum, University of Southern California:
stomach neoplasms
narrow band imaging
gastroscopy
Additional relevant MeSH terms:
Layout table for MeSH terms
Stomach Neoplasms
Metaplasia
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Pathologic Processes