NCT05791110

PE-1 in the Diagnosis of Pancreatic Exocrine Insufficiency

Diagnostic Value of Fecal Pancreatic Elastase 1 in the Diagnosis of Pancreatic Exocrine Insufficiency: a Multi-center Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,053 (actual)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The aim of this study was to evaluate and determine the clinical performance of Fecal Pancreatic Elastase 1 Test in the diagnosis of pancreatic exocrine insufficiency.

Detailed description

Fecal Pancreatic Elastase 1 (PE-1)Test has high diagnostic accuracy in pancreatic exocrine insufficiency (PEI), has become a painless noninvasive diagnostic modality in clinical practice, and has been widely used in clinical practice. However, in China, the diagnostic ability of the PE-1 test in the Chinese population has not been demonstrated and has not been reported. Meanwhile, pancreatin stimulation, 13C-mixed triglyceride breath test, and N-benzoyl-L-tyrosyl-p-aminobenzoic acid test required drugs, which cannot pass the examination of the drug administration and were not allowed to be carried out to diagnose PEI in China. In addition pancreatin stimulation is an invasive test has certain risks for subjects and 72-hour fecal fat quantification was mainly used for the diagnosis of severe PEI. Therefore, This study adopted strict clinical diagnosis as a comparative method for PE-1 test to judge the ability of PE-1 test to diagnose PEI in the Chinese population. This study aims to clarify the application efficacy of PE-1 test in PEI through a multi-center, prospective clinical study comparing PE-1 test with strict clinical diagnosis. To study the accuracy of PE-1 test in the diagnosis of PEI.

Conditions

• Pancreatic Exocrine Insufficiency

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Fecal pancreatic elastase 1 test	Fecal pancreatic elastase 1 test are immunoassays for the quantitative determination of fecal pancreatic elastase in human stool samples.

Timeline

• Start date: 2020-07-30
• Primary completion: 2021-05-30
• Completion: 2021-08-26
• First posted: 2023-03-30
• Last updated: 2023-04-13

Locations

1 site across 1 country: China