The impact of confocal endomicroscopy combined with standard diagnostics in evaluating large pancreatic cystic lesions: an international interobserver study (with video)

Document Type

Article

Publication Date

11-1-2026

Publication Title

Gastrointestinal endoscopy

Keywords

Humans, Pancreatic Cyst, Microscopy, Confocal, Female, Male, Middle Aged, Pancreatic Neoplasms, Endosonography, Prospective Studies, Aged, Observer Variation, Cystadenoma, Serous, Neuroendocrine Tumors, Cyst Fluid

Abstract

BACKGROUND AND AIMS: Current diagnostic approaches for pancreatic cystic lesions (PCLs) often result in unnecessary surgeries for benign cysts. We sought to prospectively evaluate the potential diagnostic value of endoscopic ultrasound-guided needle-based confocal laser endomicroscopy (EUS-nCLE) combined with standard-of-care (SOC) analysis in a histopathology-confirmed cohort among nCLE-naïve endosonographers.

METHODS: Subjects were enrolled from prospective studies (2020-2024) assessing EUS-nCLE for diagnosing PCLs. An international panel of 15 EUS-nCLE-naïve endosonographers participated in a 2-phase diagnostic study. In phase 1, observers reviewed clinical, imaging, and cyst fluid analysis including glucose to classify lesions and provide specific diagnoses. In phase 2, they reviewed corresponding EUS-nCLE videos and revised diagnoses when warranted. Diagnostic accuracy before and after nCLE review was compared using histopathology as the reference standard.

RESULTS: Sixty-six patients (mean cyst size = 4.3 ±1.9 cm) were included. Accuracy for distinguishing mucinous from nonmucinous PCLs increased from 90% to 96% with nCLE (P  <   .01). Subtype-specific accuracy improved for intraductal papillary mucinous neoplasm (88%-92%), mucinous cystic neoplasm (87%-91%), serous cystadenoma (88%-93%), cystic neuroendocrine tumor (91%-93%), and pseudocyst (92%-99%; all P  <  .05). Overall diagnostic accuracy improved from 73% to 85% (P  <  .01). nCLE significantly reduced misclassification, lowering mean unnecessary benign resections from 7.2 to 4.1 (P = .010) and missed neoplastic diagnoses from 4.4 to 0.7 (P = .001) per observer, enhancing clinical decision-making.

CONCLUSIONS: When combined with standard diagnostic evaluation, including cyst fluid glucose analysis, EUS-nCLE significantly enhances accuracy for classifying and identifying pancreatic cystic lesion subtypes. These results support incorporating nCLE into diagnostic algorithms, particularly for larger cysts where precise management decisions are crucial.

Medical Subject Headings

Humans; Pancreatic Cyst; Microscopy, Confocal; Female; Male; Middle Aged; Pancreatic Neoplasms; Endosonography; Prospective Studies; Aged; Observer Variation; Cystadenoma, Serous; Neuroendocrine Tumors; Cyst Fluid

PubMed ID

42413832

ePublication

ePub ahead of print

Volume

104

Issue

5

First Page

839

Last Page

848

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