A prospective, descriptive cohort study evaluating the prevalence and incidence of exocrine pancreatic insufficiency in patients with pancreatic cancer.

Pancreatic cancer is the fourth leading cause of cancer-related death in the
United States and is the second cause next to colorectal cancer of digestive
cancer-related death. The only potentially curative treatment is surgical
resection, but due to the late presentation of this disease, only 10-20% of the
patients are candidates for a pancreatectomy. The prognosis of pancreatic
cancer, even in those with a potentially resectable disease, is poor. The
five-year survival following a pancreatico¬duodenectomy is approximately 25-30%
for node negative tumors and 10% for node positive tumors. Recent data suggests
that survival may be improving over time, possibly related to improved forms of
treatment including palliative chemotherapy and (neo)adjuvant chemoradiotherapy
next to surgical resection.
Weight loss in cancer in general is amongst others caused by primary tumour
effects which instigate metabolic abnormalities such as an increased glucose
production, increased lipolysis, increased body protein breakdown and depletion
of body fat stores. Due to secondary tumour effects (e.g. side effects of
treatment, mechanical and intestinal obstruction) above mentioned effects can
be augmented. In case of pancreatic cancer, secondary tumour effects such as
pancreatic duct obstruction, replacement of parenchyma by neoplasm, gland
fibrosis and atrophy can cause exocrine pancreatic insufficiency.
Patients who develop exocrine pancreatic insufficiency due to pancreatic cancer
suffer from nutritional deficiencies resulting from the malabsorption from fat,
protein and carbohydrates. Development of exocrine pancreatic insufficiency
(early) in the course of disease is frequently overlooked, because the focus of
attention of both patient and physician is directed at chemo(radio)therapy and
its potential side effects. Loss of appetite caused by steatorrhoea associated
complaints (bloating, abdominal cramps, foul smelling, grey, frothy stools) are
frequently falsely attributed to the effects of the primary tumour.
The actual prevalence and incidence of exocrine pancreatic insufficiency in
pancreatic cancer is a relatively unknown fact.
The aim of this study is to determine the timely incidence and prevalence of
exocrine pancreatic insufficiency in pancreatic cancer by means of a repeated
elastase-1 test.

Primary Objective:
- To determine the incidence of EPI in pancreatic cancer.
Secondary Objectives are:
1. To identify the predictive factors for the development of EPI in pancreatic
cancer.
2. To evaluate the occurrence of nutritional deficiencies in pancreatic cancer.
3. To assess the efficacy of pain medication in pancreatic cancer.

This is a prospective, descriptive observational cohort study. Patients who are
recently diagnosed with pancreatic cancer will be followed during their disease
course. EPI will be evaluated by means of a monthly repeated FET.
Pancreatic enzyme replacement treatment (PERT) is started if FET < 0.1 mg/g.
In addition, each month patients will complete a short questionnaire to assess
the presence of signs and symptoms of EPI.
Every three months blood will be drawn to analyse the nutritional status.
The follow up in inoperable patients will continue as long as the condition of
the patient allows it. The follow up in operative patients will continue until
6 months after the operation.

There are no risks foreseen in joining this study.
When a exocrine pancreatic insufficiency is proven in a patient, he or she will
receive pancreatic enzyme suppletion treatment during the rest of their disease
process.