Clinical Applications and Trials

Flexible Endoscopy

Clinical trials initiated by Pentax at hospital sites throughout the world, and recent sales release of the ISC-1000 endomicroscopy product, make confocal technology available to endoscopists for applications where obtaining cellular information at the time of patient examination is advantageous. This is particularly so if extensive biopsy is considered impractical, unnecessary or may hinder the conventional endoscopic view due to bleeding. Both upper and lower GI applications under investigation include:

  • Ulcerative Colitis – surveillance for neoplasia in inflammatory bowel disease
  • Diagnosis of neoplasia during screening colonoscopy
  • Barrett’s Esophagus – diagnosis, surveillance for neoplasia and management
  • FAP – sampling multiple polyps in polyposis syndrome patients
  • Coeliac disease – monitoring disease activity and histological change in gluten intolerant patients
  • Identification of Helicobacter pylori in the gastric mucosa ( cause of ulcers and cancer)
  • Gastric cancer – diagnosis of stomach cancer and margin assessment
  • Flat adenomas and aberrant crypt foci – progression to colorectal cancer
  • Small bowel transplants – monitoring for rejection
  • Non-erosive reflux disease (NERD) - diagnosis of esophageal inflammation not evident on endoscopic examination
  • Microscopic colitis - inflammatory condition diagnosis, often missed by conventional biopsy
  • Gastric intestinal metaplasia - monitoring transformation of the stomach lining that can lead to cancer

Details of some of the clinical trial sites, investigators, research areas and results are reported at www.endomicroscopy.org.

Results from the first clinical studies at Cabrini Hospital (Melbourne, Australia) and Johannes Gutenburg University of Mainz (Mainz, Germany) were published in peer-reviewed journals in 2004/05. New applications of the technology continue to be published and presented at high-profile international conference meetings, as well as publication of several review papers describing the role of flexible endomicroscopy in GI medicine.

 

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