Narrow Band Imaging for Gastric Neoplasia
Prospective Controlled Trial of Narrow Band Imaging for Detection of Gastric Cancer Precursors
1 other identifier
interventional
220
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable gastric-cancer
Started Jul 2014
Longer than P75 for not_applicable gastric-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 18, 2014
CompletedFirst Posted
Study publicly available on registry
July 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedMarch 6, 2023
March 1, 2023
9.4 years
July 18, 2014
March 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Detection of Intestinal Metaplasia or Dysplasia
Confirmation of intestinal metaplasia in stomach per patient by each method-NBI versus white light-versus random
One Year
Secondary Outcomes (4)
Number of Regions with Intestinal Metaplasia
1 year
Number of regions with dysplasia
one year
Biopsies driven by method
One year
Helicobacter pyrlori detection
One year
Study Arms (1)
Gastric Symptoms
EXPERIMENTALPatients with gastric symptoms including dyspepsia undergoing upper endoscopy will undergo white light biopsy narrow band imaging guided biopsy protocolled biopsy
Interventions
Endoscopy with biopsies guided by high definition white light
Upper Endoscopy with Protocolled Biopsy (i.e. biopsy by predetermined guideline not influenced by white light or narrow band imaging findings)
Upper Endoscopy with biopsy guided by narrow and imaging
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Californialead
- Universidade do Portocollaborator
Study Sites (2)
Los Angeles County Hospital
Los Angeles, California, 90033, United States
Department of Gastroenterology Portuguese Oncology Institute of Porto
Porto, Portugal
Related Publications (7)
de Vries AC, van Grieken NC, Looman CW, Casparie MK, de Vries E, Meijer GA, Kuipers EJ. Gastric cancer risk in patients with premalignant gastric lesions: a nationwide cohort study in the Netherlands. Gastroenterology. 2008 Apr;134(4):945-52. doi: 10.1053/j.gastro.2008.01.071. Epub 2008 Jan 30.
PMID: 18395075BACKGROUNDDinis-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.
PMID: 22198778BACKGROUNDCapelle LG, de Vries AC, Haringsma J, Ter Borg F, de Vries RA, Bruno MJ, van Dekken H, Meijer J, van Grieken NC, Kuipers EJ. The staging of gastritis with the OLGA system by using intestinal metaplasia as an accurate alternative for atrophic gastritis. Gastrointest Endosc. 2010 Jun;71(7):1150-8. doi: 10.1016/j.gie.2009.12.029. Epub 2010 Apr 9.
PMID: 20381801BACKGROUNDden Hoed CM, Holster IL, Capelle LG, de Vries AC, den Hartog B, Ter Borg F, Biermann K, Kuipers EJ. Follow-up of premalignant lesions in patients at risk for progression to gastric cancer. Endoscopy. 2013;45(4):249-56. doi: 10.1055/s-0032-1326379. Epub 2013 Mar 26.
PMID: 23533073BACKGROUNDPimentel-Nunes P, Dinis-Ribeiro M, Soares JB, Marcos-Pinto R, Santos C, Rolanda C, Bastos RP, Areia M, Afonso L, Bergman J, Sharma P, Gotoda T, Henrique R, Moreira-Dias L. A multicenter validation of an endoscopic classification with narrow band imaging for gastric precancerous and cancerous lesions. Endoscopy. 2012 Mar;44(3):236-46. doi: 10.1055/s-0031-1291537. Epub 2012 Jan 31.
PMID: 22294194BACKGROUNDDias-Silva D, Pimentel-Nunes P, Magalhaes J, Magalhaes R, Veloso N, Ferreira C, Figueiredo P, Moutinho P, Dinis-Ribeiro M. The learning curve for narrow-band imaging in the diagnosis of precancerous gastric lesions by using Web-based video. Gastrointest Endosc. 2014 Jun;79(6):910-20; quiz 983-e1, 983.e4. doi: 10.1016/j.gie.2013.10.020. Epub 2013 Nov 26.
PMID: 24287281BACKGROUNDBuxbaum JL, Hormozdi D, Dinis-Ribeiro M, Lane C, Dias-Silva D, Sahakian A, Jayaram P, Pimentel-Nunes P, Shue D, Pepper M, Cho D, Laine L. Narrow-band imaging versus white light versus mapping biopsy for gastric intestinal metaplasia: a prospective blinded trial. Gastrointest Endosc. 2017 Nov;86(5):857-865. doi: 10.1016/j.gie.2017.03.1528. Epub 2017 Mar 30.
PMID: 28366441DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Buxbaum, MD
University of Southern California
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 18, 2014
First Posted
July 22, 2014
Study Start
July 1, 2014
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
March 6, 2023
Record last verified: 2023-03