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Optimalisation of exocrine pancreatic insufficiency and pancreatic enzyme replacement therapy in patients with periampullary cancer

Validation of diagnostic tests for exocrine pancreatic insufficiency in patients with periampullary cancer or after pancreatoduonectomy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON25332
Enrollment
100
Registered
2019-09-20
Start date
2019-09-20
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Periampullary cancer / Pancreatoduodenectomy

Interventions

None listed

Sponsors

Cancer Center Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age > 18 years 2) Written informed consent 3) Understanding of the Dutch language 4) Willing and capable of following 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) that could potentially affect the intestinal absorption or metabolism of fat 2) Gastroparesis of any aetiology 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 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 endpoint of this study is diagnostic accuracy of various diagnostic tests such as the FET, the 13C-MTG breath test and the 24-hour faecal fat quantification, Sudan stain test compared to the 72-hour faecal fat quantification to detect EPI in patients with a newly diagnosed periampullary cancer and after a PD.

Secondary

MeasureTime frame
1) Incidence of EPI at time of diagnosis of periampullary cancer and after a PD 2) Course of exocrine pancreatic function after a PD 3) Presence of micronutrient deficiencies 4) To evaluate whether the occurrence of EPI can be predicted based on the development of specific signs or symptoms

Contacts

Public ContactLotte Blonk

Amsterdam UMC, location VUmc

l.blonk@amsterdamumc.nl0204444444

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)