This is a prospective observational study which aims to evaluate; The prevalence of pancreatic insufficiency in patients with pancreatic malignancies (adenocarcinoma and neuroendocrine tumours). The most appropriate diagnostic strategy. The impact that an adequate diagnosis and treatment may have on patients' outcome.
Patients will prospectively receive a full nutritional assessment, pancreatic enzyme insufficiency (PEI) diagnosis and dietician education. This assessment will be performed as an outpatient in parallel with the medical oncology team, by the research dietician. This study will be performed in two steps (summarized in Figure 2); Step-1 \| A prospective cross-sectional assessment of the prevalence of PEI-related symptoms in up to n=150 patients with pancreatic malignancy (this will be termed 'the demographic cohort'). A sub-set of these patients (n=50) will be tested to elucidate the most efficient diagnostic panel for PEI in pancreatic malignancy (this will be termed 'the diagnosis cohort'). Step-2 \| A prospective longitudinal validation of the diagnostic panel designed and tested in Step-1 and evaluation of dietician intervention (including PERT) and its impact in weight loss, symptom evolution, chemotherapy receiving rate, Quality of Life and overall survival (this will be termed 'the follow-up cohort' and will include up to n=50 patients). All patients included in both steps will have a full nutritional assessment at baseline, and PERT treatment (as per standard of care if considered appropriate). Patients in the follow-up cohort will be reviewed (at least every 3 months for a maximum of 6 months since study entry) by dietician for further intervention and assessment.
Study Type
OBSERVATIONAL
Enrollment
112
Pancreo-Kit (Isomed Pharma, Madrid, Spain) is a breath test devised to measure Pancreatic Enzyme Insufficiency. It is a non-invasive method to obtain information about the digestion of consumed lipids; this in turn is informative about the exocrine enzyme activity of the pancreas (specifically pancreatic lipase). This kit is manufactured to EC directive 98/79/EEC and carries the CE mark. The test is based on measurement of 13C which is a stable naturally occurring environmental isotope of carbon with a nucleus containing 6 protons and 7 neutrons (note, it is not radioactive).
The Christie NHS Foundation Trust
Manchester, United Kingdom
Determine prevalence of pancreatic enzyme insufficiency in patients with pancreatic neoplasms.
Prevalence will be given as a percentage of all patients with pancreatic neoplasms with evidence of pancreatic enzyme insufficiency
Time frame: 2 years
To determine the prevalence of PEI-related symptoms at first oncological referral.
Percentage of patients with documented biochemical evidence of pancreatic enzyme insufficiency with related symptoms
Time frame: 1 year
To evaluate nutritional status of patients at the time of oncological referral (using a panel of 'standard of care' blood tests parameters).
Using defined dietetic endpoints
Time frame: 1 year
To assess the feasibility of performing the PEI breath test and the fecal elastase-1 measurement.
Described as a percentage of successful tests completed by patients
Time frame: 1 year
To assess, using the "acceptability questionnaire" (developed specifically for this study), the acceptability of these investigations by patients.
To quantify acceptability on a pre-defined score for each of the tests.
Time frame: 1 year
To identify, through semi structured interviews and thematic analysis, diet-related themes of interest in a subset of patients involved in this study
Themes will be described in a semi-quantitative report arising from the interviews.
Time frame: 1 year
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