Exosomal glypican-1 discriminates pancreatic ductal adenocarcinoma from chronic pancreatitis

Background and aims: Pancreatic ductal adenocarcinoma (PDAC) diagnosis can be difficult in a chronic pancreatitis (CP) background, especially in its mass forming presentation. We aimed to assess the accuracy of glypican-1-positive circulating exosomes (GPC1+ crExos) to distinguish PDAC from CP versus the state-of-the-art CA 19-9 biomarker. Methods: This was a unicentric prospective cohort. Endoscopic ultrasound with fine-needle aspiration or biopsy and blood tests (GPC1+ crExos and serum CA 19-9) were performed. Results: The cohort comprised 60 PDAC and 29 CP (7 of which mass forming - MF) patients. Median levels of GPC1+ crExos were significantly higher in PDAC (99.7%) versus CP (28.4%; p<0.00 01) with an AUROC of 0.96 with 98.3% sensitivity and 86.2% specificity for a cut-offof 45.0% (p<0.0 001); this outperforms CA 19-9 AUROC of 0.82 with 78.3% sensitivity and 65.5% specificity at a cut-offof 37 U/mL (p<0.0 001). The superiority of% GPC1+crExos over CA 19-99 in differentiating PDAC from CP was observed in both early (stage I) and advanced tumors (stages II-IV). Conclusion: Levels of GPC1+ crExos coupled to beads enable differential diagnosis between PDAC and CP including its mass-forming presentation. (C) 2021 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.