Clinical trial · Interventional
Narrow Band Imaging for Gastric Neoplasia
Prospective Controlled Trial of Narrow Band Imaging for Detection of Gastric Cancer Precursors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Dysplasia | — | UNRESOLVED | — |
| Gastric Metaplasia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Narrow Band Imaging Guided Biopsy | Procedure | — | UNRESOLVED |
| Protocolled | Procedure | — | UNRESOLVED |
| White light biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gastric Symptoms
- description
- Patients with gastric symptoms including dyspepsia undergoing upper endoscopy will undergo white light biopsy narrow band imaging guided biopsy protocolled biopsy
- interventionNames
- Procedure: White light biopsy
- Procedure: Protocolled
- Procedure: Narrow Band Imaging Guided Biopsy
Primary outcomes (1)
- measure
- Detection of Intestinal Metaplasia or Dysplasia
- timeFrame
- One Year
- description
- Confirmation of intestinal metaplasia in stomach per patient by each method-NBI versus white light-versus random
Secondary outcomes (4)
- measure
- Number of Regions with Intestinal Metaplasia
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDde 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 18395075
- BACKGROUNDDinis-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 22198778
- BACKGROUNDCapelle 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 20381801
- BACKGROUNDden 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 23533073
- BACKGROUNDPimentel-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.