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Gastrointest Endosc. 2019 Apr;89(4):832-841.e2. doi: 10.1016/j.gie.2018.10.049. Epub 2018 Nov 14.

Incremental value of DNA analysis in pancreatic cysts stratified by clinical risk factors.

Author information

1
Yale Center for Pancreatic Disease, Section of Digestive Disease, Yale University, New Haven, Connecticut, USA.
2
Department of Medicine, Indiana University, Indianapolis, Indiana, USA.
3
Interpace Diagnostics, Pittsburgh, Pennsylvania, USA.
4
Division of Digestive and Liver Disease, Department of Medicine, Columbia University Medical Center, New York, New York, USA.

Abstract

BACKGROUND AND AIMS:

We determined the incremental predictive value of pancreatic cyst fluid molecular analysis to assessing malignancy risk over long-term follow-up of a well-characterized cohort, given the underlying predictive value of imaging parameters routinely used to triage such patients.

METHODS:

Patients who lacked initial cytologic malignancy in cyst fluid and had final pathology or a follow-up period of more than 2 years were included. Patient outcomes determined the malignancy-free survival of patients with high-risk stigmata (HRS), worrisome features (WFs), and DNA abnormalities. DNA analysis included 3 abnormalities: loss of heterozygosity mutations among a panel of tumor suppressor genes, Kras mutation, and elevated DNA quantity.

RESULTS:

Included were 478 patients; 209 had surgical pathology-derived outcomes and 269 had clinical follow-up of >2 years. Eleven percent had malignant outcome. Forty-two patients had HRS, 272 lacked both HRS and WFs, and 164 lacked HRS but had WFs. DNA abnormalities did not statistically change long-term malignancy risk in patients with HRS or in patients lacking both HRS and WFs. Among patients with WFs, the presence of ≥2 DNA abnormalities significantly increased malignancy risk (relative risk, 5.2; P = .002) and the absence of all DNA abnormalities significantly decreased risk (relative risk, .4; P = .040). Sensitivity analysis confirmed results of survival analysis over differing baseline malignancy probabilities.

CONCLUSIONS:

Our study defines the clinical characteristic of patients in which DNA abnormality testing has the greatest impact on patient outcomes. Use of DNA abnormality testing is supported in a carefully selected patient population limited to cysts with WFs.

PMID:
30447214
DOI:
10.1016/j.gie.2018.10.049

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