The Effects of High Dose Pancreatic Enzyme Replacement Therapy After Pancreatoduodenectomy

Summary

Up to now, the studies concerning nutritional assessment after pancreatic resection were rare. The low-dose pancreatic enzyme treatment after pancreatectomy showed no significant benefit in terms of nutritional status. This study is a multicenter randomized phase IV study by using high-dose Norzyme® (40,000 IU) to evaluate quality of life and nutritional status after pancreaticoduodenectomy.

Timeline

Start

2014-04

Primary completion

2017-09-07

Completion

2017-12-31

Outcome

Missed primary endpoint

paper In the intent-to-treat analysis of data from a randomized trial, we found no significant effect of PERT on mean body weights PMID 31520730 ↗

Publications

• Kim H, Yoon YS, Han Y, Kwon W, Kim SW, Han HS, Yoon DS, Park JS, Park SJ, Han SS, Lee SE, Choi SH, Han IW, Kim E, Jang JY. Effects of Pancreatic Enzyme Replacement Therapy on Body Weight and Nutritional Assessments After Pancreatoduodenectomy in a Randomized Trial. Clin Gastroenterol Hepatol. 2020 Apr;18(4):926-934.e4. doi: 10.1016/j.cgh.2019.08.061. Epub 2019 Sep 12.

Drugs

Indications