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

John Gásdal Karstensen; Tatiana Cârţână; Codruţa Constantinescu; Silviu Dumitrașcu; Bojan Kovacevic; Pia Klausen; Hazem Hassan; Tobias Wirenfeldt Klausen; Helga Bertani; Manoop S Bhutani; Adrian Săftoiu; Peter Vilmann

doi:10.1055/s-0043-121987

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

John Gásdal Karstensen, Tatiana Cârţână, Codruţa Constantinescu, Silviu Dumitrașcu, Bojan Kovacevic, Pia Klausen, Hazem Hassan, Tobias Wirenfeldt Klausen, Helga Bertani, Manoop S Bhutani, Adrian Săftoiu, Peter Vilmann

Institut for Klinisk Medicin

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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 κ = 0.20 - 0.41 for novices and κ = -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.

Originalsprog	Engelsk
Tidsskrift	Endoscopy International Open
Vol/bind	6
Udgave nummer	1
Sider (fra-til)	E78-E85
ISSN	2196-9736
DOI	https://doi.org/10.1055/s-0043-121987
Status	Udgivet - 2018

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10.1055/s-0043-121987Licens: CC BY-NC-ND

Endoscopic ultrasound guided needle-based confocal laser endomicroscopy in solid pancreatic masses – a prospective validation studyForlagets udgivne version, 976 KBLicens: CC BY-NC-ND

Citationsformater

Karstensen, J. G., Cârţână, T., Constantinescu, C., Dumitrașcu, S., Kovacevic, B., Klausen, P., Hassan, H., Klausen, T. W., Bertani, H., Bhutani, M. S., Săftoiu, A., & Vilmann, P. (2018). Endoscopic ultrasound guided needle-based confocal laser endomicroscopy in solid pancreatic masses - a prospective validation study. Endoscopy International Open, 6(1), E78-E85. https://doi.org/10.1055/s-0043-121987

Karstensen, JG, Cârţână, T, Constantinescu, C, Dumitrașcu, S, Kovacevic, B, Klausen, P, Hassan, H, Klausen, TW, Bertani, H, Bhutani, MS, Săftoiu, A & Vilmann, P 2018, 'Endoscopic ultrasound guided needle-based confocal laser endomicroscopy in solid pancreatic masses - a prospective validation study', Endoscopy International Open, bind 6, nr. 1, s. E78-E85. https://doi.org/10.1055/s-0043-121987

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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 κ = 0.20 - 0.41 for novices and κ = -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.",

author = "Karstensen, {John G{\'a}sdal} and Tatiana C{\^a}r{\c t}{\^a}n{\u a} and Codru{\c t}a Constantinescu and Silviu Dumitrașcu and Bojan Kovacevic and Pia Klausen and Hazem Hassan and Klausen, {Tobias Wirenfeldt} and Helga Bertani and Bhutani, {Manoop S} and Adrian S{\u a}ftoiu and Peter Vilmann",

year = "2018",

doi = "10.1055/s-0043-121987",

language = "English",

volume = "6",

pages = "E78--E85",

journal = "Endoscopy International Open",

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TY - JOUR

T1 - Endoscopic ultrasound guided needle-based confocal laser endomicroscopy in solid pancreatic masses - a prospective validation study

AU - Karstensen, John Gásdal

AU - Cârţână, Tatiana

AU - Constantinescu, Codruţa

AU - Dumitrașcu, Silviu

AU - Kovacevic, Bojan

AU - Klausen, Pia

AU - Hassan, Hazem

AU - Klausen, Tobias Wirenfeldt

AU - Bertani, Helga

AU - Bhutani, Manoop S

AU - Săftoiu, Adrian

AU - Vilmann, Peter

PY - 2018

Y1 - 2018

N2 - 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 κ = 0.20 - 0.41 for novices and κ = -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.

AB - 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 κ = 0.20 - 0.41 for novices and κ = -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.

U2 - 10.1055/s-0043-121987

DO - 10.1055/s-0043-121987

M3 - Journal article

C2 - 29344564

SN - 2196-9736

VL - 6

SP - E78-E85

JO - Endoscopy International Open

JF - Endoscopy International Open

IS - 1

ER -

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

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