Placebo controlled trial of enteric coated pancreatin microsphere treatment in patients with unresectable cancer of the pancreatic head region

M J Bruno,^a E B Haverkort,^b G P Tijssen,^c G N J Tytgat,^a D J van Leeuwen^a

^a Division of Gastroenterology and Hepatology, ^b Department of Dietetics, ^c Department of Clinical Epidemiology and Biostatistics, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands

Correspondence to: Dr M J Bruno, Academic Medical Centre, Division of Gastroenterology and Hepatology, Room C2-321, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.

Accepted for publication 24 June 1997

BackgroundImpeded flow of pancreatic juice due to mechanical obstruction of the pancreatic duct in patients with cancer of the pancreatic head region causes exocrine pancreatic insufficiency with steatorrhoea and creatorrhoea. This may contribute to the profound weight loss that often occurs in these patients.
AimsTo investigate whether pancreatic enzyme replacement therapy prevents this weight loss.
PatientsTwenty one patients with unresectable cancer of the pancreatic head region with suspected pancreatic duct obstruction, a biliary endoprosthesis in situ, and a Karnofsky performance status greater than 60. 
MethodsRandomised double blind trial of eight weeks with either placebo or high dose enteric coated pancreatin enzyme supplementation. All patients received dietary counselling.
ResultsThe mean difference in the percentage change of body weight was 4.9% (p=0.02, 95% confidence interval for 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 kg). The fat absorption coefficient in patients on pancreatic enzymes improved by 12% whereas in placebo patients it dropped by 8% (p=0.13, 95% confidence interval for the difference: -6 to 45). The daily total energy intake was 8.42 MJ in patients on pancreatic enzymes and 6.66 MJ in placebo patients (p=0.04, 95% confidence interval for the difference: 0.08 to 3.44).
ConclusionsWeight loss in patients with unresectable cancer of the pancreatic head region and occlusion of the pancreatic duct can be prevented, at least for the period immediately after insertion of a biliary endoprosthesis, by high dose enteric coated pancreatin enzyme supplementation in combination with dietary counselling.
(GUT 1998;42:92-96)

Keywords: pancreatic cancer;  weight loss;  pancreatic enzyme therapy;  enteric coated enzyme therapy;  palliation;  dietary counselling