Optimalisation of exocrine pancreatic insufficiency and pancreatic enzyme replacement therapy.

Completed

• Conditions: Exocrine pancreatic insufficiency; impaired exocrine pancreatic function; 10015674; 10017991

• Registration Number: NL-OMON52709
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

1) Age * 18 years;
2) Written informed consent;
3) Understanding of the Dutch language;
4) Willing and capable of following the instructions for this study;
5) Patients need to be able to achieve a minimal daily dietary fat intake of *
60 grams.

Exclusion Criteria

1) Any known gastrointestinal disease or major gastrointestinal surgery (apart
from a PD, esophagectomy, gastrectomy) that could potentially affect the
intestinal absorption or metabolism of fat (e.g. short bowel, irritable bowel
disease, cystic fibrosis, chronic pancreatitis among others).
2) Gastroparesis of any aetiology (not applicable for group III and IV) .
3) Serious concomitant systemic disorders that would compromise the safety of
the patient or his/her ability to complete the study, at the discretion of the
treating physician.
4) Patients who are unable to cease anti-diarrheal medication or laxatives,
based on the physician*s experience.
5) Patients who are suspected not to be reliable in participating in this
study, based on the physician*s experience.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measure is diagnostic accuracy of easy diagnostic test(s) and<br /><br>the presence of steatorrhea-related symptoms to diagnose EPI, compared to the<br /><br>72-hour faecal fat quantification.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- presence of micronutrient deficiencies<br /><br>- incidence of EPI in this patient group<br /><br>- evaluate whether the occurrence of EPI can be predicted based of specific<br /><br>signs and symptoms<br /><br>- evaluate the effect of changes in therapy based on the results of the<br /><br>diagnostic tests included in this study<br /><br>- evaluate the effect of EPI on overall quality of life in postoperative<br /><br>patients </p><br>