Clinical usefulness of KRAS mutational analysis in the diagnosis of pancreatic adenocarcinoma by means of endosonography‐guided fine‐needle aspiration biopsy

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Abstract
Summary: Aim : To establish the usefulness of KRAS mutational analysis in the diagnosis of pancreatic adenocarcinoma by comparing this technique with conventional cytology in aspirates obtained by endosonography‐guided fine‐needle aspiration.Methods : All consecutive patients with pancreatic focal lesions undergoing endosonography‐guided fine‐needle aspiration were included. Samples were obtained with the concourse of an attendant cytopathologist. Detection of codon‐12 KRAS mutations was performed by the restriction fragment length polymorphism‐polymerase chain reaction method. The effectiveness of conventional cytology, KRAS mutational analysis and their combination was established with respect to the definitive diagnosis. A cost‐effectiveness analysis was also performed.Results : Thirty‐three patients had pancreatic adenocarcinoma and 24 patients had other lesions. A total of 136 samples was obtained. In patients in whom specimens were adequate (93% for cytology; 100% for mutational analysis), the specificity of both techniques was 100%, whereas the sensitivity favoured cytology (97% vs. 73%). When inadequate samples were considered as misdiagnosed, a combination of both techniques reached the highest overall accuracy (cytology, 91%; mutational analysis, 84%; combination of both, 98%).Conclusions : Cytology from aspirates obtained by endosonography‐guided fine‐needle aspiration is the most precise single technique for the diagnosis of pancreatic adenocarcinoma. However, when adequate specimens are not available to reach a cytological diagnosis, the addition of KRAS mutational analysis represents the best strategy.

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