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Exocrine Pancreatic Insufficiency in Pancreatic Surgery (EPIPS): A prospective multicenter study

Exocrine Pancreatic Insufficiency in Pancreatic Surgery (EPIPS): A prospective multicenter study - EPIPS

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON37197
Enrollment
120
Registered
2012-11-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

exocrine pancreatic insufficiency malabsorption

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Group A * Patients who will undergo a pancreatoduodenectomy for a suspected pancreatic or peri-ampullary malignancy ;Group B * Patients who underwent pancreatoduodenectomy for suspected pancreatic or peri-ampullary malignancy at least two years previously

Exclusion criteria

Exclusion criteria: Patients younger than 18 years

Design outcomes

Primary

MeasureTime frame
The primary outcome parameters are the presence of EPI (FE1—

Secondary

MeasureTime frame
Secondary outcome parameters are symptoms of EPI (according to the CTC-AE score), the occurrence of vitamin A, D, E, and K deficiencies and a prolonged INR, endocrine pancreatic insufficiency (HbA1c > 42 mmol/l and/or use of oral antidiabetics or insulin), Quality-of-life (RAND-36, QLQ-C30, and QLQ-PAN26), and the effect of pancreatic enzyme supplementation on symptoms of EPI.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)