Trial record 51 of 67 for:    gastroenterology | Recruiting | Exclude Unknown | United States

Narrow Band Imaging for Gastric Neoplasia

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Southern California
Sponsor:
Collaborator:
Universidade do Porto
Information provided by (Responsible Party):
James Buxbaum, University of Southern California
ClinicalTrials.gov Identifier:
NCT02197351
First received: July 18, 2014
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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 Intervention
Gastric Cancer
Gastric Metaplasia
Gastric Dysplasia
Procedure: White light biopsy
Procedure: Protocolled
Procedure: Narrow Band Imaging Guided Biopsy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Prospective Controlled Trial of Narrow Band Imaging for Detection of Gastric Cancer Precursors

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Detection of Intestinal Metaplasia or Dysplasia [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Confirmation of intestinal metaplasia in stomach per patient by each method-NBI versus white light-versus random


Secondary Outcome Measures:
  • Number of Regions with Intestinal Metaplasia [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of Region with Intestinal Metaplasia detected in the stomach (total not per patient) detected by each method-NBI versus white light-versus random

  • Number of regions with dysplasia [ Time Frame: one year ] [ Designated as safety issue: No ]
    Number of regions with dysplasia detected in the stomach (total not per patient) detected by each method-NBI versus white light-versus random

  • Biopsies driven by method [ Time Frame: One year ] [ Designated as safety issue: No ]
    Number of biopsies driven by each method. Number driven by each method-NBI versus white light-versus random will be compared.

  • Helicobacter pyrlori detection [ Time Frame: One year ] [ Designated as safety issue: No ]
    Detection ofHelicobacter pylori by method


Estimated Enrollment: 220
Study Start Date: July 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02197351

Contacts
Contact: James Buxabum, MD 323 409 5371 jbuxbaum@usc.edu
Contact: Maria Trujillo 323 409 0939 mit@usc.edu

Locations
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
Principal Investigator: James Buxbaum, MD University of Southern California
  More Information

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.

Responsible Party: James Buxbaum, Assistant Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT02197351     History of Changes
Other Study ID Numbers: HS-14-00418
Study First Received: July 18, 2014
Last Updated: August 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
stomach neoplasms
narrow band imaging
gastroscopy

Additional relevant MeSH terms:
Stomach Neoplasms
Metaplasia
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014