PLACEBO-CONTROLLED TRIAL OF ENTERIC-COATED PANCREATIN MICROSPHERE TREATMENT IN PATIENTS WITH UNRESECTABLE CANCER OF THE PANCREATIC HEAD REGION

Background-Impeded flow of pancreatic juice due to mechanical obstruct ion of the pancreatic duct in patients with cancer of the pancreatic h ead region causes exocrine pancreatic insufficiency with steatorrhoea and creatorrhoea. This may contribute to the profound weight loss that often occurs in these patients.Aims-To investigate whether pancreatic enzyme replacement therapy prevents this weight loss. Patients-Twenty one patients with unresectable cancer of the pancreatic head region w ith suspected pancreatic duct obstruction, a biliary endoprosthesis in situ, and a Karnofsky performance status greater than 60, Methods-Ran domise double blind trial of eight weeks with either placebo or high d ose enteric coated pancreatin enzyme supplementation. All patients rec eived dietary counselling. Results-The mean difference in the percenta ge change of body weight was 4.9% (p = 0.02, 95% confidence interval f or the difference: 0.9 to 8.9). Patients on pancreatic enzymes gained 1.2% (0.7 kg) body weight whereas patients on placebo lost 3.7% (2.2 k g). The fat absorption coefficient in patients on pancreatic enzymes i mproved by 12% whereas in placebo patients it dropped by 8% (p = 0.13, 95% confidence interval for the difference: - 6 to 45). The daily tot al energy intake was 8.42 MJ in patients on pancreatic enzymes and 6.6 6 MJ in placebo patients (p = 0.04, 95% confidence interval for the di fference: 0.08 to 3.44). Conclusions-Weight loss in patients with unre sectable cancer of the pancreatic head region and occlusion of the pan creatic duct can be prevented, at least for the period immediately aft er insertion of a biliary endoprosthesis, by high dose enteric coated pancreatin enzyme supplementation in combination with dietary counsell ing.