Pancreatic Fluid Enzymes as a Functional Chronic Pancreatitis Biomarker: A Pilot Endoscopic Study.

OBJECTIVE: We previously validated a short endoscopic test with pancreas fluid enzyme activity in pediatrics and young adults. We assessed the role of pancreatic fluid enzyme activity as a candidate to address the lack of a diagnostic biomarker for chronic pancreatitis (CP). METHODS: In this pilot study, we assessed pancreatic fluid samples collected endoscopically 30-minute post-secretin injection from adult controls (n=10) and CP subjects (n=20). Protein-normalized enzymatic activity for amylase, lipase, trypsin, chymotrypsin, and elastase was compared between CP and control groups using logistic regression, and diagnostic performance was evaluated by ROC analysis. RESULTS: Acinar cell enzyme levels were decreased in pancreatic fluid from CP subjects compared with controls, with significant differences observed for lipase and trypsin activity (AUC≥0.82; p's=0.01). Eighty-six percent of controls had normal enzymatic activity across all five analytes, compared with only 43% of CP subjects, who more frequently exhibited multi-enzyme abnormalities. A graded pattern of reduction was observed from controls to equivocal (Eq) CP to definitive (Def) CP, indicating that enzyme activity generally shifts with advancing CP disease, although Eq and Def CP did not differ significantly from one another. CONCLUSIONS: This pilot study explored the potential of pancreatic fluid enzymatic activity as a functional assessment of exocrine activity in CP, with potential correlation to disease severity. Pancreatic fluid represents a promising, proximal biomarker source; however, larger prospective studies are needed to validate pancreas fluid biomarkers and define their relationship to disease stage, EPD, and other CP-related clinical outcomes.