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Endoscopic ultrasound guided needle-based confocal laser endomicroscopy in solid pancreatic masses - a prospective validation study.

ABSTRACT: Background and study aims:?Endoscopic ultrasound fine-needle aspiration (EUS-FNA) is a keystone in diagnosing and staging of pancreatic masses. Recently, a microfiber that can pass through a 19-gauge needle has been introduced for confocal laser endomicroscopy (nCLE). The aims of this study were to evaluate the diagnostic value and the reproducibility of nCLE criteria for solid malignant lesions. Patients and methods:?This prospective dual-center study included patients with pancreatic masses suspicious of malignancy referred for EUS-FNA. Endomicroscopic imaging was performed under EUS-guidance until organ-specific structures were obtained. Afterwards, standard cytology was obtained and patients were followed for up to 12 months. All nCLE parameters included in former studies were correlated with the final diagnosis (dark lobular structures/normal acinar cells, dark cell aggregates?>?40?µm, dilated irregular vessels with fluorescein leakage, fine white fibrous bands, small black cell movements, pseudoglandular structures). Finally, three CLE novices and three CLE experts assessed the unedited movies from all patients. Results:?Twenty-eight patients were enrolled in the study. A final diagnosis was obtained in 24 patients (86?%). One patient (3?%) died before a diagnosis was obtained, while 3 were lost to follow-up (11?%). In 18/24 patients (74?%) the diagnosis was malignant. The mean sensitivity, specificity, and accuracy for the nCLE parameters ranged from 19?-?93 %, 0?-?56?%, 26?-?69?%, respectively. The inter-observer values ranged from ??=?0.20?-?0.41 for novices and ??=?-0.02?-?0.38 for experts. Conclusions:?The diagnostic value of nCLE in solid pancreatic masses is questionable and the inter-observer agreement for both novices and CLE experts appears limited.

SUBMITTER: Karstensen JG

PROVIDER: S-EPMC5770262 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Endoscopic ultrasound guided needle-based confocal laser endomicroscopy in solid pancreatic masses - a prospective validation study.

Karstensen John Gásdal JG Cârţână Tatiana T Constantinescu Codruţa C Dumitrașcu Silviu S Kovacevic Bojan B Klausen Pia P Hassan Hazem H Klausen Tobias Wirenfeldt TW Bertani Helga H Bhutani Manoop S MS Săftoiu Adrian A Vilmann Peter P

Endoscopy international open 20180116 1

<h4>Background and study aims</h4> Endoscopic ultrasound fine-needle aspiration (EUS-FNA) is a keystone in diagnosing and staging of pancreatic masses. Recently, a microfiber that can pass through a 19-gauge needle has been introduced for confocal laser endomicroscopy (nCLE). The aims of this study were to evaluate the diagnostic value and the reproducibility of nCLE criteria for solid malignant lesions.<h4>Patients and methods</h4> This prospective dual-center study included patients with pancr ...[more]

PMID: 29344564

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Project description:Endoscopic ultrasound-guided needle-based confocal laser endomicroscopy (EUS-nCLE) has been shown to aid in the diagnosis of cystic pancreatic lesions. This is a pilot project to study its findings in patients with solid pancreatic lesions (SPLs) with a prospective single-blinded study design.Patients with SPLs undergoing trans-gastric EUS fine needle aspiration (EUS-FNA) from July 2013 to March 2014 were prospectively enrolled. The nCLE diagnoses were compared with the final diagnoses. Researchers learned about the EUS-nCLE findings from previously published studies and applied it to diagnose SPLs. In the meantime, the findings were recorded.In total, 22 patients were recruited (mean age 62.7 years, SD 13.8 years; 14 men and eight women). The mean maximal tumor diameter was 36.0 mm (SD 10.9 mm). EUS-nCLE yielded satisfactory images in all patients during the first EUS procedure and diagnosed benign and malignant SPLs in 3 and 19 patients, respectively. Final diagnoses of malignant SPLs were made in 19 patients. Benign SPLs were eventually diagnosed in three patients, with confirmed the cytology and disease stability during the 12-month follow-up period. At the end of the project, based on the results of this current study, EUS-nCLE findings for malignant SPLs were dark clumping with or without dilated vessels (> 40 μm). There were two criteria for diagnosing benign lesions which were white fibrous bands and normal acini cells. The accuracy rate of EUS-nCLE was 90.9 % (20/22). One falsely diagnosed malignant SPL was an inflammatory mass from a recent acute pancreatitis. Another one with a pancreatic neuroendocrine tumor presenting with a symptomatic pseudocyst was incorrectly diagnosed as an inflammatory mass. This was likely from sampling error of the EUS-nCLE probe in an inflammatory area. Only one patient had post EUS-FNA bleeding but did not require a blood transfusion. The inter-observer agreement among three blinded endoscopists was almost perfect (Kappa 0.82).EUS-nCLE is a promising technique for the diagnosis of SPLs with good inter-observer agreement. Study registration‎: TCTR20140402001.

Dataset Information

Endoscopic ultrasound guided needle-based confocal laser endomicroscopy in solid pancreatic masses - a prospective validation study.

Publications

Endoscopic ultrasound guided needle-based confocal laser endomicroscopy in solid pancreatic masses - a prospective validation study.

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