Based on a pilot study from the Amsterdam University Medical Center, we hypothesize that the FET is possibly less accurate to detect EPI in patients with pancreatic cancer and after a pancreatoduodenectomy (PD).
ID
Bron
Verkorte titel
Aandoening
Periampullary cancer / Pancreatoduodenectomy
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
In patients with cancer of the periampullary region, weight loss is a serious problem, affecting 80% already at diagnosis. For this, both primary and secondary tumour effects are responsible. Exocrine pancreatic insufficiency (EPI) is a secondary tumour effect, in which the pancreas is unable to deliver sufficient pancreatic enzymes into the small intestinal lumen to digest food. It may occur due to gland atrophy, obstruction of the pancreatic duct, anatomical changes or removal of functional pancreatic tissue after surgery. A shortage of pancreatic enzymes causes maldigestion, primarily of fat, leading to steatorrhea-related symptoms, weight loss, malnutrition, and an impaired quality of life. To prevent these symptoms patients should be treated with an adequate dosage of pancreatic enzymes. The gold standard to diagnose EPI is the 72-hour faecal fat quantification. This is a time-consuming and burdensome test, as patients need to follow a strict diet of 80-100 grams of fat during 5 days and collect all stool during the last 72 hours. The Faecal Elastase-1 Test (FET), is currently mostly used in clinical practice, as only a small stool sample is needed without any dietary restrictions. Previous studies, including a pilot study from the Amsterdam University Medical Center, suggest that the FET is possibly less accurate to detect EPI in patients with pancreatic cancer and after a pancreatoduodenectomy (PD). Aim of this study is to investigate the value of several diagnostic tests, including a shortened version of the current gold standard test, to detect EPI in these patients.
Doel van het onderzoek
Based on a pilot study from the Amsterdam University Medical Center, we hypothesize that the FET is possibly less accurate to detect EPI in patients with pancreatic cancer and after a pancreatoduodenectomy (PD).
Onderzoeksopzet
Not applicable
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8038 |
| Ander register | METC VUmc : METC 2019.210 |