研究目的
Comparing the accuracy of endoscopic ultrasound (EUS)-guided needle-based confocal laser endomicroscopy (nCLE) in differentiating mucinous from non-mucinous pancreatic cystic lesions (PCLs) with that of measurement of carcinoembryonic antigen (CEA) and cytology analysis.
研究成果
The study demonstrated that EUS-nCLE has higher accuracy for diagnosing mucinous PCLs compared to SOC methods (CEA measurement and cytology analysis). The sensitivity, specificity, and accuracy of EUS-nCLE were 98%, 94%, and 97%, respectively, in differentiating mucinous from non-mucinous PCLs. These findings suggest that EUS-nCLE can be a valuable tool in the evaluation of PCLs, although further multicenter studies are needed to validate these results and define the role of EUS-nCLE in clinical practice.
研究不足
1. The study was conducted at a single center, which may limit the generalizability of the findings. 2. The interpretation of nCLE images was performed by endosonographers unblinded to demographic characteristics and imaging results, potentially introducing bias. 3. The sample size for individual types of PCLs was relatively small, leading to imprecise estimates for diagnosing PCL subtypes. 4. The study population had a high prevalence of worrisome features, which may not be representative of all pancreatic cysts.
1：Experimental Design and Method Selection:
A prospective study design was employed to evaluate the diagnostic accuracy of EUS-nCLE versus standard of care (SOC) methods (CEA measurement and cytology analysis) in differentiating mucinous from non-mucinous PCLs.
2：Sample Selection and Data Sources:
Consecutive patients with suspected PCLs (≥20 mm) referred for EUS-FNA evaluation were enrolled. Surgical histopathology served as the reference standard for diagnostic confirmation.
3：List of Experimental Equipment and Materials:
EUS with a 19-gauge needle preloaded with an AQ-Flex nCLE miniprobe (Cellvizio, Mauna Kea Technologies, Paris, France) was used for image acquisition. Fluorescein was injected intravenously for contrast.
4：Experimental Procedures and Operational Workflow:
EUS-nCLE was performed by experienced endosonographers. The intracystic endomicroscopic video was captured, followed by cyst fluid aspiration for CEA and cytology analysis.
5：Data Analysis Methods:
Diagnostic accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated with 95% exact binomial confidence intervals (CI) for each diagnostic method. McNemar’s test for paired proportions was used to compare the accuracy of EUS-nCLE versus SOC.
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