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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38667

Enrollment

200

Registered

2014-02-04

Start date

2014-06-03

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Cohort A • Patients who will undergo a pancreatoduodenectomy for a suspected or confirmed pancreatic or peri-ampullary (pre-) malignancy. • Informed consent;Cohort B • Patients who underwent a PD for suspected or confirmed pancreatic or peri-ampullary (pre-) malignancy at least two years previously. • Informed consent

Exclusion criteria

Exclusion criteria: • Patients younger than 18 years • Other causes of fat malabsorption (inflammatory bowel disease, cystic fibrosis, celiac disease, major gastrointestinal surgery other than PD).

Design outcomes

Primary

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

Secondary

Measure	Time 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), QOL (EQ-5D, QLQ-C30, and QLQ-PAN26), and the course of EPI over time.	—

Countries

Netherlands

Outcome results