Treatment of pancreatic exocrine insufficiency after pancreatic resection. Results of a randomized, double-blind, placebo-controlled, crossover study of high vs standard dose pancreatin.

Background: Steatorrhea following major pancreatic resection can be difficult to control, requiring high doses of pancreatic enzyme supplements. The aim of this study was to demonstrate equivalent efficacy of high-dose and standard-dose pancreatin in treating steatorrhea after pancreatectomy.

Methods: A randomized, double-blind, crossover study was conducted with a 2-wk run-in period for stabilization on a suitable dose of standard-dose pancreatin and two 14-d treatment periods using either high-dose or standard-dose pancreatin at this dosage. Parameters used to demonstrate efficacy of treatment were stool fat excretion, stool volume, and clinical symptoms.

Results: Thirty-nine patients who had undergone total or partial pancreatectomy were randomised; 37 completed all parts of the study. During stabilization, the mean daily capsule intake was 19.4 (range 9-54); even so, 22 (56%) patients had stool fat excretion > 7 g/d. There were significant correlations between stool fat excretion and stool volume (p < 0.0001) and stool frequency (p < 0.01), but not with indices of abdominal pain and global symptoms. Both high-dose and standard-dose pancreatin demonstrated statistically similar efficacy in the treatment period.

Conclusion: The use of high-dose pancreatin for the treatment of pancreatic insufficiency in patients following pancreatectomy should significantly reduce capsule intake with increased convenience and greater compliance rate. Our results, however, indicate that further progress is needed to resolve steatorrhea following pancreatic resection.