PE-1 in the Diagnosis of Pancreatic Exocrine Insufficiency

Launched by CHANGHAI HOSPITAL · Mar 17, 2023

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - 【patients with clinical diagnosed PEI】
• • 1. Inpatients or outpatients of both sexes, aged 18 to 80 years.
• • 2. Patients with pancreatic disease or after pancreatic or gastric resection (one of the following)
• • 1. Chronic pancreatitis.
• • 2. At least 3 months after pancreatectomy (surgical procedures included total pancreatectomy, pancreaticoduodenectomy, pylorus-preserving pancreaticoduodenectomy, and distal pancreatectomy).
• • 3. Patients recovering from severe acute pancreatitis (duration less than 24 months).
• • 4. More than 3 months after gastrectomy (surgical methods included total gastrectomy, proximal gastrectomy, and distal gastrectomy).
• • 3. Enrolled patients had at least one of the following symptoms (except those after pancreatectomy)
• • 1. abdominal distension.
• • 2. Weight loss (weight loss is defined as loss of more than 5% of basal body weight in one year).
• • 3. steatorrhea.
• • 4. Agreed to participate in the study and signed an informed consent form.
• • 【patients without clinical diagnosed PEI】
• • 1. Both male and female, aged between 18 and 80 years old.
• 2. Patients who met one of the following criteria were included in the study:
• • 1. Patients with functional gastrointestinal diseases who had no history of pancreatectomy, gastrectomy, or abdominal radiotherapy were included.
• • 2. Healthy volunteers.
• • 3. Patients with benign hepatobiliary diseases, thyroid, breast diseases, and digestive tract diseases who had no history of pancreatectomy, gastrectomy, or abdominal radiotherapy were included.
• • 3. Agreed to participate in the study and signed an informed consent form.
• Exclusion Criteria:
• • 1. Pregnant women
• • 2. Critically ill patients
• • 3. The subjects with mental disorders were unable to cooperate with the researchers
• • 4. patients who had undergone ileocolon bladder replacement surgery or complicated with intestinal obstruction and other diseases that could not collect feces
• • 5. the quantity of fecal samples, storage and transportation conditions of samples do not meet the requirements of the kit
• • 6. patients who underwent two or more times of gastrectomy or pancreatectomy