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Optimalisation of exocrine pancreatic insufficiency and pancreatic enzyme replacement therapy.

Optimalisation of exocrine pancreatic insufficiency and pancreatic enzyme replacement therapy. - OPPERT-study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON52709
Enrollment
150
Registered
2019-08-30
Start date
2019-10-04
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Exocrine pancreatic insufficiency impaired exocrine pancreatic function

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Primary outcome measure is diagnostic accuracy of easy diagnostic test(s) and the presence of steatorrhea-related symptoms to diagnose EPI, compared to the 72-hour faecal fat quantification.

Secondary

MeasureTime frame
- presence of micronutrient deficiencies - incidence of EPI in this patient group - evaluate whether the occurrence of EPI can be predicted based of specific signs and symptoms - evaluate the effect of changes in therapy based on the results of the diagnostic tests included in this study - evaluate the effect of EPI on overall quality of life in postoperative patients

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)