Management of Patients With Pancreatic Cysts: Analysis of Possible False-Negative Cases of Malignancy.

"T.K. reports a consultancy relationship with BSCI outside of the submitted work. N.H. reports a consultancy relationship with Boston Scientific outside of the submitted work. M.K. reports a research grant to his institution from RedPath during the conduct of the study and acknowledges support to his institution from The Ron Foley Foundation (http://www.ronsrun.org), West Hartford, CT, outside of the submitted work. M.F.C. reports a research grant from RedPath to his institution during the conduct of the study. M.A.A.-H. reports a research grant from RedPath to his institution during the conduct of the study and personal fees from AbbVie, Boston Scientific, and Forest outside of the submitted work. The remaining authors declare that they have nothing to disclose."

"This analysis was funded in part by RedPath Integrated Pathology Inc. (now Interpace Diagnostics Corporation). Helen Varley, PhD, CMPP (Excel Scientific Solutions, Horsham, UK) provided writing assistance per ICMJE guidelines, which was supported by RedPath."

"The study design and patient population have been reported previously. Briefly, adults with a pancreatic cyst and negative, nondiagnostic, indeterminate or acellular cytology results who therefore had cyst/duct fluid aspirate tested by IMP were included. Exclusion criteria included previous pancreatic cancer and any treatment for pancreatic lesions before IMP test. Clinical outcomes were determined by retrospective review of patient medical records documented in the National Pancreatic Cyst Registry (10 academic and private institutions in the United States) and categorized as “benign” or “malignant pancreatic adenocarcinoma.” Further information on data abstraction from medical records is provided in the Supplemental Methods (Supplemental Digital Content 1, http://links.lww.com/JCG/A252). Benign outcomes included surgical pathology demonstrating a benign cyst or low/intermediate-grade dysplasia, resolution of cyst on repeat imaging, and imaging follow-up for ≥23 months without evidence of malignant outcome. Patients with follow-up imaging of <23 months were excluded unless clear benign or malignant clinical end points occurred within this timeframe. Malignant outcomes were malignant cytology results (unknown during IMP diagnosis), clinically confirmed pancreatic cancer, death attributed to pancreatic cancer, and HGD. Only cases where the malignant outcome related specifically to the lesion tested by FNA were included. The date of malignant outcome was defined as the earliest date at which a definitive diagnosis of malignancy could be made."