February 10, 2015
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GI experts offer recommendations for Cellvizio

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Cellvizio, a probe-based confocal laser endomicroscopy system, should be routinely implemented to improve diagnostic evaluation and management strategies for Barrett’s esophagus, biliary strictures, colorectal lesions and inflammatory bowel diseases, and training practices should be standardized, according to consensus recommendations written by international experts.

Cellvizio (Mauna Kea Technologies) “has taken a very important role in the evaluation of a growing number of gastrointestinal pathologies,” Jean-Paul Galmiche, MD, FRCP, MWGO, from the division of gastroenterology and hepatology at University Hospital in Nantes, France, said in a press release. “In order to standardize its use around the world, it was necessary to start developing a first set of recommendations for some key indications of the technology.”

Jean-Paul Galmiche, MD, FRCP, MWGO

Jean-Paul Galmiche

Barrett’s esophagus

The experts recognized that probe-based confocal laser endomicroscopy (pCLE) has utility in the evaluation of Barrett’s esophagus for many clinical situations. They agreed that pCLE:

  • should complement endoscopic evaluation;
  • should be combined with red-flag techniques;
  • is indicated in patients with dysplasia in lesions identified endoscopically in surveillance or with electronic enhancement;
  • can detect goblet cells to differentiate intestinal and nonintestinal metaplasia;
  • is superior to white light endoscopy in identifying intestinal metaplasia;
  • reduces need for physical biopsy for known Barrett’s with endoscopically benign-appearing esophagus when random sampling result is negative;
  • improves yield for neoplasia compared with white light endoscopy and random biopsy;
  • improves detection of dysplasia when added to white light endoscopy-targeted biopsy;
  • can be used to decide therapeutic intervention for endoscopically neoplastic-appearing esophagus when random sampling result is positive;
  • can define location and lateral extent of neoplasia before therapy; and
  • should be cited as a valuable tool in official surveillance guidelines.

Biliary strictures

According to the authors, “pCLE enables microscopic evaluation of the bile duct mucosa, which enhances the imaging arsenal of the physician and increases accuracy of the procedure.”  For the evaluation and management of biliary strictures, the experts agreed that pCLE:

  • can evaluate biliary strictures and the probe can be delivered by catheter or cholangioscope;
  • has superior accuracy in differentiating malignant and benign strictures compared with endoscopic retrograde cholangiopancreatography (ERCP) with brush cytology and/or forceps biopsy;
  • has high negative predictive value;
  • can improve clinical decision making; and
  • should be cited as a valuable tool in official guidelines.
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Colorectal lesions

The authors wrote that the value of pCLE in characterizing colorectal lesions has been established for many years, but it needs to be recognized in scientific society guidelines to be applied in daily clinical practice. For evaluation and management of colorectal lesions, the experts agreed that pCLE:

  • accurately identifies normal colonic mucosa, adenomatous neoplasia, hyperplastic polyps and colorectal carcinoma;
  • improves imaging when combined with red-flag techniques;
  • accurately classifies diminutive colonic polyps when combined with digital chromoendoscopy;
  • provides accurate real-time histopathological classification of colonic neoplasia in situ;
  • criteria can be used to characterize colonic tissue in real time during endoscopy or offline during sequence review;
  • is sufficient for deciding on resection based on diagnosis of intramucosal cancer and/or high-grade dysplasia;
  • can provide real-time guidance for extend of therapy for residual neoplasia after endoscopic mucosal resection (EMR) when combined with digital chromoendoscopy;
  • should be considered for identifying extent of flat lesions;
  • is useful for treatment and surveillance after EMR (3-12 months) or endoscopic submucosal dissection (ESD) of advanced polyps; and
  • obviates need for repeat EMR or ablation when it determines the absence of residual neoplasia in combination with chromoendoscopy. 

Inflammatory bowel disease

Consensus report statements for IBD “were largely based on the integration of CLE into practice changes from the current management algorithm to an individualized one,” the authors wrote. They agreed that for IBD, pCLE:

  • should be used with an individualized approach;
  • can acquire targeted-biopsies for surveillance, which are preferred over random four-quadrant biopsies;
  • identifies histological changes in vivo for both Crohn’s disease and ulcerative colitis, including in macroscopically non-inflamed mucosa (which should be used for surveillance);
  • provides live information about intestinal barrier function and vascular permeability;
  • diagnoses novel predictors of disease course;
  • can redefine “mucosal healing” in vivo;
  • can detect more dysplastic and early neoplastic lesions in long-standing ulcerative colitis with systematic sampling;
  • should be used with the ultimate goal of predicting response to anti-tumor necrosis factor treatment; and
  • should be combined with red-flag techniques. 

 “We believe that these evidence-based consensus positions provide strong additional support for expanded use of pCLE in GI applications,” Galmiche said in the release. “These statements could help with establishment of necessary guidelines and promise an improvement in the standardization of the pCLE practice.”

The expert panel also developed consensus statements on training and credentialing, which are provided in the appendix of the consensus report. – by Adam Leitenberger

Disclosure: Galmiche reports he is a consultant for Mauna Kea Technologies. Please see the full study for a list of all other authors’ relevant financial disclosures.