Comparison of Probe-Based Confocal Laser Endomicroscopy With Virtual Chromoendoscopy for Classification of Colon Polyps

doi:10.1053/j.gastro.2009.10.053

Gastroenterology

Volume 138, Issue 3, March 2010, Pages 834-842

https://doi.org/10.1053/j.gastro.2009.10.053 Get rights and content

Background & Aims

Probe-based confocal laser endomicroscopy (pCLE) allows in vivo imaging of tissue at micron resolution. Virtual chromoendoscopy systems, such as Fujinon intelligent color enhancement and narrow band imaging, also have potential to differentiate neoplastic colorectal lesions. The accuracy of these systems in clinical practice is, however, unknown. Our primary aim was to compare sensitivity and specificity of pCLE to virtual chromoendoscopy for classification of colorectal polyps using histopathology as a gold standard. A secondary aim was to compare sensitivity and specificity of pCLE to virtual chromoendoscopy using a modified gold standard that assumed that all polyps ≥10 mm had malignant potential and were considered neoplastic or high risk.

Methods

Patients underwent colonoscopy using high-resolution colonoscopes. The surface pit pattern was determined with NBI or FICE in all patients. Confocal images were recorded and subsequently analyzed offline, blinded to the endoscopic characteristics and histopathology. Each polyp was diagnosed as benign or neoplastic based on confocal features according to modified Mainz criteria.

Results

A total of 119 polyps (81 neoplastic, 38 hyperplastic) from 75 patients was assessed. The pCLE had higher sensitivity compared to virtual chromoendoscopy when considering histopathology as gold standard (91% vs 77%; P = .010) and modified gold standard (88% vs 76%; P = .037). There was no statistically significant difference in specificity between pCLE and virtual chromoendoscopy when considering histopathology or modified gold standard.

Conclusions

Confocal endomicroscopy demonstrated higher sensitivity with similar specificity in classification of colorectal polyps. These new methods may replace the need for ex vivo histological confirmation of small polyps, but further studies are warranted.

Section snippets

Patients

The study was approved by Mayo Clinic Institutional Review Board, and full informed consent was obtained from all study participants. Patients were enrolled if they were due for surveillance or screening colonoscopies, evaluation of known or suspected polyps on other imaging modalities, and endoscopic mucosal resection of larger flat colorectal neoplasia. Exclusion criteria were patients with noncorrected coagulopathy, women who were pregnant or breast feeding, documented allergy to

General Characteristics of Patients

Table 1 illustrates demographic and general characteristics of patients with colorectal lesions (35 women and 40 men). Median age of patients at the time of colonoscopy was 73 years (range, 44−91 years). None of the patients experienced any endoscopic complications or adverse reaction to sodium fluorescein, with the exception of transient yellow discoloration of the skin and urine, which resolved by the time of discharge from the recovery room (skin) or within 24 hours (urine).

Histopathology and Morphological Classification of Colorectal Lesions

Of the 119

Discussion

A probe-based confocal laser endomicroscopy system is a new tool that allows cellular and subcellular micron-level imaging of colonic mucosa during endoscopy without requirement of the use of a designated endoscope. In this study, we demonstrated that pCLE system can image colonic mucosa and further analyze the cellular and architectural features of the colonic mucosa in vivo. Use of fluorescein sodium was safe and tolerated by all patients. Based on the confocal analysis of crypts and vessels

Acknowledgments

Clinical Trial Registration Number: NCT 00874263.

A preliminary report of this study was presented at the AGA Late Breaking Abstract Forum, Digestive Disease Week, 2008.

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The presence of neoplastic changes (adenomas and cancer) could be predicted with high accuracy (sensitivity, 97.4%; specificity, 99.4%; accuracy, 99.2%). Buchner et al43 evaluated the role of probe-based confocal laser endomicroscopy to characterize colonic polyps. The methodology was compared with virtual chromoendoscopy.
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Conflicts of interest The authors disclose the following:

Dr Wallace receives research grant support from Mauna Kea Technologies. He has received support for educational conferences below the federal threshold for reporting conflicts of interest.

The statistical analysis of the entire data sets pertaining to efficacy (specifically, primary and major secondary endpoints) and safety (specifically, serious adverse events as defined in federal guidelines) have been independently confirmed by a biostatistician who is not employed by the corporate entity; and Dr Wallace had full access to all of the data and takes full responsibility for the veracity of the data and analysis. The remaining authors disclose no conflicts.

: Funding Supported by the American Society of Gastrointestinal Endoscopy Research Award, American College of Gastroenterology, and the Mayo Clinic Foundation for Research and Education.

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Imaging and Advanced TechnologyComparison of Probe-Based Confocal Laser Endomicroscopy With Virtual Chromoendoscopy for Classification of Colon Polyps

Background & Aims

Methods

Results

Conclusions

Section snippets

Patients

General Characteristics of Patients

Histopathology and Morphological Classification of Colorectal Lesions

Discussion

Acknowledgments

Gastrointest Endosc

Gastroenterology

Gastroenterology

Am J Gastroenterol

Gastroenterology

Gastrointest Endosc

Clin Gastroenterol Hepatol

Gastrointest Endosc

Gastrointest Endosc

Gastrointest Endosc

Clin Gastroenterol Hepatol

Colorectal cancer prevention

J Clin Oncol

Adenomatous and hyperplastic polyps cannot be reliably distinguished by their appearance through the fiberoptic sigmoidoscope

Dig Dis Sci

High accuracy of narrow band imaging without magnification for the real-time characterization of polyp histology and its comparison with high-definition white light colonoscopy: a prospective study

Am J Gastroenterol

Imaging and Advanced Technology
Comparison of Probe-Based Confocal Laser Endomicroscopy With Virtual Chromoendoscopy for Classification of Colon Polyps