Open label randomized, multicentre, controlled trial of pancreatic enzyme replacement therapy (PERT) for pancreatic exocrine insufficiency (PEI) in patients with unresectable pancreatic cancer.

Pancreatic exocrine insufficiency

The primary endpoint is defined as the change in body weight (kg and percentage) from baseline to the end of the controlled phase, 3 months from inclusion, as well as to the end of the study, 6 months from inclusion, in the two groups of patients.

Change in haemoglobin, lymphocytes, serum concentration of nutritional markers (albumin, prealbumin, retinol binding protein, transferrin, fat-soluble vitamins, total and HDL cholesterol, triglycerides, cholinesterase, magnesium, selenium, and zinc), HbA1C and C-reactive protein (CRP) from baseline to the end of the controlled phase (3 months) and the end of the study (6 months) in the two groups of patients, Change in Karnofsky performance status from baseline to the end of the controlled phase and the end of the study in the two groups of patients, Change in malabsorption-related symptoms (diarrhoea, flatulence, abdominal distention, meteorism, abdominal cramps) and Patient-Generated Subjective Global Assessment (PG-SGA) from baseline to the end of the controlled phase and the end of the study in the two groups of patients, Change in quality of life (EORTC QLQ-PAN26) from baseline to the end of the controlled phase and the end of the study in the two groups of patients, Tolerance to chemotherapy defined as the percentage of the optimal dose of chemotherapeutic agents administered at months 3 and 6 from inclusion, Survival over 3 and 6 months from inclusion

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