IDDF2023-ABS-0288 Diagnostic value of fecal PE-1 test in pancreatic exocrine insufficiency

Background

PE-1 test has become a painless and non-invasive diagnostic method for the diagnosis of pancreatic exocrine insufficiency (PEI) in clinical practice and is widely used in clinical practice. However, there is no effective method to diagnose PEI in China and the diagnostic accuracy of PE-1 test in the Chinese population has not been demonstrated. This study aims to clarify the application efficacy of PE-1 test in PEI through a multicenter clinical study comparing PE-1 test with strict clinical diagnosis to study the accuracy of the PE-1 test in the diagnosis of PEI.

Methods

Each subject underwent rigorous clinical diagnosis and fecal PE-1 test. Patients with PEI-related clinical symptoms such as abdominal distension, weight loss or steatorrhea after chronic pancreatitis, pancreatectomy or gastrectomy, and Convalescence of severe acute pancreatitis were diagnosed with PEI patients; Healthy volunteers and patients with functional gastrointestinal disorders, benign hepatobiliary diseases, thyroid diseases, breast diseases, digestive tract diseases, excluding pancreatic disease, pancreatectomy, gastrectomy, abdominal radiotherapy were diagnosed as non-PEI. Fecal samples from the volunteers were detected using the pancreatic elastase 1 detection kit from ScheBo Biotech AG, Germany.

Results

We enrolled 1053 subjects (525 PEI patients and 528 non-PEI patients) from Changhai Hospital, Shanghai, China, Peking Union Medical College Hospital and Xuanwu Hospital, Beijing, China between July 30, 2020, and August 26, 2021. The fecal elastase 1 mean concentration in PEI patients was much lower than that in non-PEI patients (88.59 vs 568.05). The fecal PE-1 test was consistent with clinical diagnosis in the diagnosis of PEI (Kappa=0.884,95%CI 0.857,0.911, P<0.0001). The sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio of the PE-1 test in the diagnosis of PEI were 90.10%, 98.3%, 52.86, 0.10. The accuracy of PE-1 test in the diagnosis of PEI was 94.21%.

Conclusions

PE-1 test has a good diagnostic value for pancreatic exocrine insufficiency and is recommended for the diagnosis of PEI in the Chinese population.