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Detection ofKRASGene Mutations in Endoscopic Ultrasound-Guided Fine-Needle Aspiration Biopsy for Improving Pancreatic Cancer Diagnosis

Wang, Xiaowei MD1,2; Gao, Jun MD1,2; Ren, Yan MD1; Gu, Junjun MD1; Du, Yiqi MD1; Chen, Jie MD1; Jin, Zhendong MD1; Zhan, Xianbao MD1; Li, ZhaoShen PhD1; Huang, Haojie MD1; Lv, ShunLi MD1; Gong, Yanfang MD1

American Journal of Gastroenterology: December 2011 - Volume 106 - Issue 12 - p 2104–2111
doi: 10.1038/ajg.2011.281

OBJECTIVES: Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNAB) is a useful tool in the diagnosis of pancreatic masses. Genetic analysis of these samples could increase the sensitivity and specificity of diagnosis. This study aimed to evaluate the usefulness of a novel method for the detection of mutations in theKRAS(Kirsten rat sarcoma-2 virus) gene for the diagnosis of pancreatic cancer.

METHODS: EUS-FNABs were performed on 82 patients with pancreatic masses, including 54 cases of pancreatic ductal adenocarcinoma and 28 of non-malignant pancreatic masses. The biopsies were histopathologically and cytopathologically evaluated, and the detection ofKRASgene mutations (codons 12 and 13) was performed through peptide nucleic acid-directed polymerase chain reaction clamping and DNA sequencing.

RESULTS: In the pancreatic cancer cases, 88.9% (48/54; 95% confidence interval (CI): 80.5–97.2%) hadKRASmutations, while 61.1% (33/54; 95% CI: 48.1–74.1%) were unequivocally diagnosed by histo/cytopathology. In the indeterminate patients (n=49; diagnosed by EUS-FNA as either insufficient material to make a diagnosis, no malignancy, or suspicion of malignancy), there were 10 cases of pancreatic cancer with low serum carbohydrate antigen 19-9 (CA19-9) (<37 U/l) and 6 of these wereKRASmutations. The sensitivity of detection byKRASmutations (76.2%) and the combination ofKRASmutations and serum CA19-9 (81%) were significantly higher than for serum CA19-9 alone (52.4%). A logistic regression model showed that theKRASmutation was significant (odds ratio=5.830; CI: 1.531–22.199,P=0.01), but not serum CA19-9. In the non-malignant pancreatic masses (n=28),KRASmutations were detected in nine precancerous lesions.

CONCLUSIONS: Our method for the detection ofKRASgene mutations may be useful to supplement histo/cytopathologic evaluations for pancreatic cancer, and is superior to serum CA19-9 in EUS-FNAB histo/cytopathology-indeterminate patients. Results warrant further verification in other patient populations.

1Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China

2These authors contributed equally to this work

Correspondence: ZhaoShen Li, MD, PhD, Department of Gastroenterology, Changhai Hospital, Second Military Medical University, 168 Changhai Road, Shanghai 200433, China. E-mail:

published online 30 August 2011

Received 30 July 2010; accepted 27 July 2011

© The American College of Gastroenterology 2011. All Rights Reserved.
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