Narrow Band Imaging for Gastric Neoplasia
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.
Procedure: White light biopsy
Procedure: Narrow Band Imaging Guided Biopsy
|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|
- 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
- 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
|Study Start Date:||July 2014|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
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 lightProcedure: 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02197351
|Contact: James Buxabum, MD||323 409 email@example.com|
|Contact: Maria Trujillo||323 409 firstname.lastname@example.org|
|United States, California|
|Los Angeles County Hospital||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Maria Trujillo 323-409-6939 email@example.com|
|Contact: James Buxbaum, MD 323 409 5371 firstname.lastname@example.org|
|Department of Gastroenterology Portuguese Oncology Institute of Porto||Not yet recruiting|
|Contact: Mario Dinis-Ribeiro, MD +351-22-5084055 email@example.com|
|Contact: Diogo Dias da Silva, MD firstname.lastname@example.org|
|Principal Investigator: Mario Dinis-Ribeiro, MD|
|Sub-Investigator: Diogo Dias da Silva, MD|
|Principal Investigator:||James Buxbaum, MD||University of Southern California|