BACKGROUND AND AIM: Probe-based confocal laser endomicroscopy (pCLE) provides real-time microscopic visualisation. Our aim was to compare the diagnostic accuracy of pCLE with standard biopsies in patients with visible oesophageal or gastric lesions. METHODS: This was a single-centre, prospective, pathologist-blinded study. Patients underwent high-resolution endoscopy, and lesions were examined by pCLE followed by standard biopsies. A definitive diagnosis was determined from resection specimen. Main outcomes were overall diagnostic accuracy, sensitivity, specificity and positive and negative predictive values. RESULTS: We examined 74 lesions in 67 patients. Definitive diagnoses revealed 34 malignant and 40 non-malignant lesions. pCLE diagnosis was correct in 89.2% (66/74), while diagnosis based on biopsy was correct in 85% (57/67; p = 0.6). The overall diagnostic accuracy of biopsies was 85% (76-94%) and that of pCLE was 89% (79-96%). pCLE correctly diagnosed malignant lesions, comprising oesophageal adenocarcinoma, oesophageal squamous-cell cancer or gastric adenocarcinoma, in 88.2% (30/34) of cases, while biopsy was correctly diagnosed in 75.9% (22/29; p = 0.3). Sensitivity and specificity to diagnose a malignant lesion were 75.9% (95% confidence interval (CI) 56-89%) and 100% (95% CI 90-100%) for biopsies and 88.2% (95% CI 72-97%) and 92% (95% CI 79-98%) for pCLE. No differences between biopsies and pCLE were found with regard to sensitivity, specificity to diagnose dysplastic and benign lesions (p > 0.2). CONCLUSION: pCLE provides satisfactory diagnostic accuracy comparable with standard biopsies in patients with oesophageal or gastric lesions. ClinicalTrials.gov identifier: NCT0292049).
- MeSH
- Adenocarcinoma diagnosis pathology MeSH
- Biopsy statistics & numerical data MeSH
- Adult MeSH
- Endoscopy, Gastrointestinal instrumentation methods statistics & numerical data MeSH
- Microscopy, Confocal instrumentation methods statistics & numerical data MeSH
- Lasers MeSH
- Middle Aged MeSH
- Humans MeSH
- Esophageal Neoplasms diagnosis pathology MeSH
- Stomach Neoplasms diagnosis pathology MeSH
- Prospective Studies MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Sensitivity and Specificity MeSH
- Esophageal Mucosa diagnostic imaging pathology MeSH
- Carcinoma, Squamous Cell diagnosis pathology MeSH
- Gastric Mucosa diagnostic imaging pathology MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial MeSH
- Research Support, Non-U.S. Gov't MeSH
- Comparative Study MeSH
- MeSH
- Models, Biological MeSH
- Time Factors MeSH
- Chondrocytes cytology MeSH
- Research Support as Topic MeSH
- Cartilage, Articular anatomy & histology MeSH
- Microscopy, Confocal statistics & numerical data MeSH
- Humans MeSH
- Cadaver MeSH
- Temperature MeSH
- Tissue Preservation methods MeSH
- Check Tag
- Humans MeSH
- Publication type
- Comparative Study MeSH
