Optimalisation of exocrine pancreatic insufficiency and pancreatic enzyme replacement therapy in patients with periampullary cancer
- Conditions
- Periampullary cancer / Pancreatoduodenectomy
- Registration Number
- NL-OMON25332
- Lead Sponsor
- Cancer Center Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1) Incidence of EPI at time of diagnosis of periampullary cancer and after a PD<br>2) Course of exocrine pancreatic function after a PD<br>3) Presence of micronutrient deficiencies<br>4) To evaluate whether the occurrence of EPI can be predicted based on the development of specific signs or symptoms