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

Withdrawn

• Conditions: exocrine pancreatic insufficiency; malabsorption; 10015674

• Registration Number: NL-OMON37197
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 120

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

Patients younger than 18 years

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome parameters are the presence of EPI (FE1<200) and the<br /><br>percentage of patients that is under treated for EPI, i.e. patients who should<br /><br>receive treatment for EPI based on fecal elastase 1 test and patients who are<br /><br>treated for EPI but still experience symptoms reflecting EPI. </p><br>

Secondary Outcome Measures

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