Unreliability of the Fecal Pancreatic Elastase-1 Test In Predicting a Response to Pancreatic Enzyme Replacement

The fecal elastase-1 assay is the most frequently used screening test for pancreatic enzyme insufficiency (PEI). It has a sensitivity of 73%, with lower sensitivities for mild and moderate PEI. Reliance on this test has resulted in "ruling out" PEI in patients with undiagnosed chronic gastrointestinal complaints. Some of these patients will respond dramatically to a simple and safe trial of pancreatic enzyme replacement.

A list of all fecal elastase-1 tests performed at VA Connecticut during calendar year 2025 was obtained (N=102). The charts of patients with elastase-1 results in the low-normal to mid-normal range (200-800 mcg/gram) were reviewed (N=34). There were 10 patients with ongoing gastrointestinal complaints without a definitive diagnosis despite extensive laboratory, endoscopic, and radiological investigations and empiric trials of fiber, bile acid binding resins, and antibiotics. These patients were contacted and offered an empiric two-week trial of pancreatic enzyme replacement.

Five patients had clinically significant responses to pancreatic enzyme replacement with dramatic improvement in their quality of life. They are now on chronic replacement therapy.

Overreliance on the stool elastase-1 test has resulted in missed opportunities to help patients with chronic gastrointestinal complaints.