Needle-based confocal laser endomicroscopy for the diagnosis of pancreatic cystic lesions: an international external interobserver and intraobserver study (with videos)

Somashekar G. Krishna, William R. Brugge, John M. Dewitt, Pradermchai Kongkam, Bertrand Napoleon, Carlos Robles-Medranda, Damien Tan, Samer El-Dika, Sean McCarthy, Jon Walker, Mary E. Dillhoff, Andrei Manilchuk, Carl Schmidt, Benjamin Swanson, Zarine K. Shah, Phil A. Hart, Darwin L. Conwell

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Abstract

Background and Aims EUS-guided needle-based confocal laser endomicroscopy (nCLE) characteristics of common types of pancreatic cystic lesions (PCLs) have been identified; however, surgical histopathology was available in a minority of cases. We sought to assess the performance characteristics of EUS nCLE for differentiating mucinous from non-mucinous PCLs in a larger series of patients with a definitive diagnosis. Methods Six endosonographers (nCLE experience >30 cases each) blinded to all clinical data, reviewed nCLE images of PCLs from 29 patients with surgical (n = 23) or clinical (n = 6) correlation. After 2 weeks, the assessors reviewed the same images in a different sequence. A tutorial on available and novel nCLE image patterns was provided before each review. The performance characteristics of nCLE and the κ statistic for interobserver agreement (IOA, 95% confidence interval [CI]), and intraobserver reliability (IOR, mean ± standard deviation [SD]) for identification of nCLE image patterns were calculated. Landis and Koch interpretation of κ values was used. Results A total of 29 (16 mucinous PCLs, 13 non-mucinous PCLs) nCLE patient videos were reviewed. The overall sensitivity, specificity, and accuracy for the diagnosis of mucinous PCLs were 95%, 94%, and 95%, respectively. The IOA and IOR (mean ± SD) were κ = 0.81 (almost perfect); 95% CI, 0.71-0.90; and κ = 0.86 ± 0.11 (almost perfect), respectively. The overall specificity, sensitivity, and accuracy for the diagnosis of serous cystadenomas (SCAs) were 99%, 98%, and 98%, respectively. The IOA and IOR (mean ± SD) for recognizing the characteristic image pattern of SCA were κ = 0.83 (almost perfect); 95% CI, 0.73-0.92; and κ = 0.85 ± 0.11 (almost perfect), respectively. Conclusions EUS-guided nCLE can provide virtual histology of PCLs with a high degree of accuracy and inter- and intraobserver agreement in differentiating mucinous versus non-mucinous PCLs. These preliminary results support larger multicenter studies to evaluate EUS nCLE. (Clinical trial registration number: NCT02516488.)

Original languageEnglish (US)
Pages (from-to)644-654.e2
JournalGastrointestinal Endoscopy
Volume86
Issue number4
DOIs
StatePublished - Oct 2017

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

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    Krishna, S. G., Brugge, W. R., Dewitt, J. M., Kongkam, P., Napoleon, B., Robles-Medranda, C., Tan, D., El-Dika, S., McCarthy, S., Walker, J., Dillhoff, M. E., Manilchuk, A., Schmidt, C., Swanson, B., Shah, Z. K., Hart, P. A., & Conwell, D. L. (2017). Needle-based confocal laser endomicroscopy for the diagnosis of pancreatic cystic lesions: an international external interobserver and intraobserver study (with videos). Gastrointestinal Endoscopy, 86(4), 644-654.e2. https://doi.org/10.1016/j.gie.2017.03.002