Exocrine Pancreatic Insufficiency in Pancreatic Surgery (EPIPS): A prospective multicenter study

The pancreas has both an endocrine and exocrine function. Exocrine pancreatic
insufficiency (EPI) and vitamin deficiency after pancreatoduodenectomy is
described in 33-90% of cases. These data are based on personal experiences and
short-term results from retrospective studies. To date, there are no
prospective studies that describe exocrine pancreatic insufficiency on both
short-and long-term after pancreatoduodenectomy.

To analyze the incidence and course of EPI, before and after a PD for a
suspected pancreatic or peri-ampullary malignancy. Furthermore, the effect of
pancreatic enzyme supplementation on symptoms of EPI and the correlation of
symptoms and abnormal fecal elastase 1 test will be evaluated. In addition, the
prevalence of fat-soluble vitamin deficiencies and osteoporosis will be
evaluated. Finally, the endocrine function and quality-of-life will be
analysed.

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
during the first 18 months after surgery, to evaluate short-term EPI. The
second cohort (group B) will be followed for the same period, and consists of
patients who have already survived at least 2 years after surgery, to evaluate
the long-term EPI course.

A potential benefit of participation is early diagnosis and adequate treatment
of (subclinical) EPI. Even without personal benefit for participating patients,
this study is of great importance to the treatment of EPI and the related
benefits in nutrional status and quality of life.
All study related investigations will take place during routine follow-up
moments (including the inclusion visit there will be 5 appointments in group A
and 4 in group B). Therefore, patients will not suffer the burden of additional
hospital visits. Each visit will include a short questionnaire (5-10 minutes)
and the examination of a stool sample, which patients can obtain at the privacy
of their own home. We acknowledge a small burden, but consider these tests
without risk. In addition blood samples will be drawn to assess vitamin A, D, E
and K status and blood glucose levels (total 14mL blood). This may be perceived
as a small burden, but has negligible risks.