The objective of a study was to compare high-definition white-light endoscopy ( HDWLE ) alone with random biopsy ( RB ) and HDWLE plus eCLE ( endoscope-based confocal laser endomicroscopy system ) and targeted biopsy ( TB ) for diagnosis of Barrett's esophagus neoplasia.
This was a multicenter, randomized, controlled trial of 192 adult patients with Barrett's esophagus undergoing routine surveillance or referred for early neoplasia during the period 2010-2012 at academic medical centers.
Patients were randomized to HDWLE plus RB ( group 1 ) or HDWLE with eCLE and TB ( group 2 ).
Real-time diagnoses and management plans were recorded after HDWLE in both groups and after eCLE in group 2. Blinded expert pathology diagnosis was the reference standard.
The main outcomes were diagnostic yield, performance characteristics, and clinical impact.
HDWLE plus eCLE and TB ( group 2 ) led to a lower number of mucosal biopsies and higher diagnostic yield for neoplasia ( 34% vs 7% ), compared with HDWLE and RB ( group 1 ) but with comparable accuracy.
HDWLE plus eCLE and TB tripled the diagnostic yield for neoplasia ( 22% vs 6% ) and would have obviated the need for any biopsy in 65% of patients.
The addition of eCLE to HDWLE increased the sensitivity for neoplasia detection to 96% from 40% without significant reduction in specificity.
In vivo CLE changed the treatment plan in 36% of patients.
An eCLE was performed successfully and safely in all patients.
There were no adverse reactions to fluorescein administration.
The researchers noted several limitations including that the study was only at academic centers with highly experienced endoscopists. The results may not be generalizable to community-based physicians, less-experienced practitioners and nonacademic practices. Second, they used the eCLE system, and their findings may not be generalizable to other pCLE systems.
Also, the endoscopists were not blinded to prior endoscopy and pathology results because these were necessary for standard medical care and in vivo decision making regarding biopsy or EMR.
The researchers have concluded that the addition of in vivo imaging with eCLE to HDWLE is associated with improved targeting of neoplasia, a decrease in unnecessary mucosal biopsies and a significant change in diagnosis and management plans in patients with Barrett's esophagus.
The approach of real-time CLE diagnosis and imaging-guided therapy represents a potential paradigm shift in Barrett's esophagus surveillance.
Research studies are needed to address training in CLE, comparative effectiveness studies of advanced endoscopic imaging techniques, the role of imaging-guided therapy and advances in CLE devices and contrast agents. ( Xagena )
Source: American Society for Gastrointestinal Endoscopy ( ASGE ), 2014