Gastric Cancer Clinical Trial
Official title:
Prospective Controlled Trial of Narrow Band Imaging for Detection of Gastric Cancer Precursors
NCT number | NCT02197351 |
Other study ID # | HS-14-00418 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2014 |
Est. completion date | December 2023 |
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.
Status | Recruiting |
Enrollment | 220 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Portugal | Department of Gastroenterology Portuguese Oncology Institute of Porto | Porto | |
United States | Los Angeles County Hospital | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of Southern California | Universidade do Porto |
United States, Portugal,
Capelle 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. — View Citation
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. — View Citation
den 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. — View Citation
Dias-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. — View Citation
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. — View Citation
Pimentel-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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of Regions with Intestinal Metaplasia | Number of Region with Intestinal Metaplasia detected in the stomach (total not per patient) detected by each method-NBI versus white light-versus random | 1 year | |
Secondary | Number of regions with dysplasia | Number of regions with dysplasia detected in the stomach (total not per patient) detected by each method-NBI versus white light-versus random | one year | |
Secondary | Biopsies driven by method | Number of biopsies driven by each method. Number driven by each method-NBI versus white light-versus random will be compared. | One year | |
Secondary | Helicobacter pyrlori detection | Detection ofHelicobacter pylori by method | One year |
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