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Laboratory study on the diagnosis of pancreatic exocrine insufficiency (PEI) with fecal elastase -1 (FE-1)

Laboratory study on the diagnosis of pancreatic exocrine insufficiency (PEI) with fecal elastase -1 (FE-1)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000032120
Enrollment
Unknown
Registered
2020-04-20
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic exocrine insufficiency

Interventions

Gold Standard: Pancreatic exocrine function tests can be used to aid in the diagnosis of PEI, and are divided into direct and indirect tests. Direct testing is the gold standard for detecting pancr
Index test:Faecal&#32
elastase,FE-1&#32

Sponsors

Huadong Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) aged >= 20 year, male or female; 2) patients after partial pancreatectomy; 3) total pancreatectomy for the latter; 4) there were a total of 300 healthy patients in all age groups (including: 20-49 years old, 50-59 years old, 60-69 years old, 70-79 years old and >= 80 years old). There were 5 groups, including 50 patients in each group and 100 patients in each group aged >= 80 years old, 50-59 years old, 60-69 years old, 70-79 years old and >= 80 years old. 5) the patient volunteered to participate and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1) abnormal stool routine examination; 2) those with severe constipation and unable to defecate autonomously; 3) women with combined pregnancy or breastfeeding; 4) patients with tumor or high fever, severe infection or severe heart, brain, liver and kidney disease; 5) organic gastrointestinal lesions, gastrointestinal surgery history; 6) patients with gastrointestinal bleeding; 7) patients with systemic metabolic diseases, such as abnormal thyroid function and diabetes; 8) patients with a history of pancreatic trauma; 9) patients with any chronic or acute disease with unstable conditions, which is expected to affect the efficacy evaluation and completion of the study; 10) patients with a history of cerebral apoplexy, mental disorders, consciousness disorders and coma; 11) patients participating in other clinical studies and taking drugs within 3 months; 12) * this entry is only for 300 subjects in the healthy group: (1) history of acute and chronic pancreatic disease, history of pancreatic surgery; (2) Those who had taken somatostatin or aprotinin in the last 2 weeks, or those who had taken the above mentioned drugs and had known exocrine pancreatic insufficiency or pancreatic exocrine function; (3) drugs that alter fat absorption (e.g., orlistat, other weight-loss drugs, ursodeoxycholic acid) in the last 2 weeks (4) BMI>= 24 kg/m2; (5) hypertriglyceridaemia>1.7mmol/L; (6) Anemia (female: Hemoglobin < 11g/L; Male: Hemoglobin < 12g/L).

Design outcomes

Primary

MeasureTime frame
Fecal elastase-1 (FE-1);SEN, SPE, ACC, AUC of ROC;

Countries

China

Contacts

Public ContactWei Zhang

Digestive Department, Huadong Hospital

zhangrf1973@163.com+86 13601729600

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026