To analyze the incidence and course of EPI, before and after a PD for a (suspected) pancreatic or peri-ampullary (pre-)malignancy. Furthermore, the correlation between the presence of EPI and symptoms will be evaluated. In addition, the incidence of…
ID
Source
Brief title
Condition
- Exocrine pancreas conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameters are the presence of EPI (FE1<200) and the
percentage of patients that is under treated for EPI, i.e. patients who should
receive treatment for EPI based on fecal elastase 1 test and patients who are
treated for EPI but still experience symptoms reflecting EPI.
Secondary outcome
Secondary outcome parameters are symptoms of EPI (according to the CTC-AE
score), the occurrence of vitamin A, D, E, and K deficiencies and a prolonged
INR, endocrine pancreatic insufficiency (HbA1c > 42 mmol/l and/or use of oral
antidiabetics or insulin), QOL (EQ-5D, QLQ-C30, and QLQ-PAN26), and the course
of EPI over time.
Background summary
Exocrine pancreatic insufficiency (EPI) is caused by loss of pancreatic
parenchyma (e.g. after surgical resection) or obstruction of the pancreatic
duct (e.g. tumour) and leads to loss of quality of life (QOL) and potential
worsened long term outcome. Furthermore, EPI is easily treatable with
pancreatic enzyme replacement therapy.
Following a pancreatoduodenectomy (PD) EPI is observed in 33-90% of patients.
However, these data are based on small retrospective studies. To date, there
are no multicenter prospective studies that have investigated the (course of)
exocrine pancreatic function after a PD, neither on the short-term, nor on the
long-term.
We hypothesize that EPI is frequently underdiagnosed which may be related to
the variable signs and symptoms associated with EPI. This may lead to under
treatment, high prevalence of vitamin deficiencies, osteopenia/osteoporosis and
poor QOL.
Study objective
To analyze the incidence and course of EPI, before and after a PD for a
(suspected) pancreatic or peri-ampullary (pre-)malignancy. Furthermore, the
correlation between the presence of EPI and symptoms will be evaluated. In
addition, the incidence of fat-soluble vitamin deficiencies and osteopenia/
-porosis will be evaluated. Finally, endocrine pancreatic function and QOL will
be analysed.
Study design
In this prospective multicenter observational cohort study, the presence of EPI
will be evaluated in two groups; the first group (cohort A) will be followed
before and during the first 18 months after PD, to evaluate short-term EPI. The
second cohort (cohort B) will also be followed for 18 months, but consists of
patients who have already survived at least 2 years after PD, to evaluate the
long-term EPI course.
Study burden and risks
The burden associated with participation consists of the drawing of blood
samples and the collection of a stool sample. In addition, subjects will be
asked to complete a questionnaire. Patients in cohort B will also have a DEXA
scan. There are no risks associated with participation.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
Cohort A
• Patients who will undergo a pancreatoduodenectomy for a suspected or confirmed pancreatic or peri-ampullary (pre-) malignancy.
• Informed consent;Cohort B
• Patients who underwent a PD for suspected or confirmed pancreatic or peri-ampullary (pre-) malignancy at least two years previously.
• Informed consent
Exclusion criteria
• Patients younger than 18 years
• Other causes of fat malabsorption (inflammatory bowel disease, cystic fibrosis, celiac disease, major gastrointestinal surgery other than PD).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43502.041.13 |