title: Do pancrelipase delayed-release capsules have a protective role against nonalcoholic fatty liver disease after pancreatoduodenectomy in patients with pancreatic cancer? A randomized controlled trial.
abstract: BACKGROUND
  The aim of this randomized controlled trial (RCT) was to investigate whether pancrelipase protects against nonalcoholic fatty liver disease (NAFLD) development after pancreatoduodenectomy in patients with pancreatic cancer better than conventional pancreatic enzyme supplementation.
  
  
  METHODS
  A total of 57 patients were randomly assigned to the study group (n = 29; pancrelipase replacement therapy) or the control group (n = 28; conventional pancreatic enzyme supplementation). NAFLD was defined as a liver-to-spleen attenuation ratio less than 0.9 on CT. Clinical and laboratory findings were also assessed.
  
  
  RESULTS
  NAFLD was observed in 6/29 patients (21%) in the study group, and 11/28 patients (39%) in the control group, but this was not a statistically significant difference. In the control group, crossover to pancrelipase replacement therapy upon NAFLD diagnosis produced improvement in five out of 10 patients. Multivariate analysis showed that advanced age and extended resection were independent risk factors for NAFLD development.
  
  
  CONCLUSIONS
  This RCT did not show a significant protective effect of pancrelipase replacement therapy over conventional pancreatic enzyme supplementation on NAFLD development after pancreatoduodenectomy for pancreatic cancer. Further studies are clearly required to investigate the etiology of and new therapeutic strategies for treatment-resistant NAFLD (UMIN 000019817).
authors.affiliation: Department of Surgery, Kansai Medical University, Hirakata, Osaka, Japan.
authors.forename: Sohei
authors.initials: S
authors.lastname: Satoi
authors.affiliation: Department of Surgery, Nara Medical University, Kashihara, Nara, Japan.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Sho
authors.affiliation: Department of Surgery, Kansai Medical University, Hirakata, Osaka, Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Yanagimoto
authors.affiliation: Department of Surgery, Kansai Medical University, Hirakata, Osaka, Japan.
authors.forename: Tomohisa
authors.initials: T
authors.lastname: Yamamoto
authors.affiliation: Department of Surgery, Nara Medical University, Kashihara, Nara, Japan.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Akahori
authors.affiliation: Department of Surgery, Nara Medical University, Kashihara, Nara, Japan.
authors.forename: Shoichi
authors.initials: S
authors.lastname: Kinoshita
authors.affiliation: Department of Surgery, Nara Medical University, Kashihara, Nara, Japan.
authors.forename: Minako
authors.initials: M
authors.lastname: Nagai
authors.affiliation: Department of Surgery, Kansai Medical University, Hirakata, Osaka, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Hirooka
authors.affiliation: Department of Surgery, Kansai Medical University, Hirakata, Osaka, Japan.
authors.forename: So
authors.initials: S
authors.lastname: Yamaki
authors.affiliation: Department of Surgery, Nara Medical University, Kashihara, Nara, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Nishiwada
authors.affiliation: Department of Surgery, Kansai Medical University, Hirakata, Osaka, Japan.
authors.forename: Hironori
authors.initials: H
authors.lastname: Ryota
authors.affiliation: Department of Surgery, Nara Prefectural Seiwa Medical Center, Nara City, Nara, Japan.
authors.forename: Naoya
authors.initials: N
authors.lastname: Ikeda
authors.affiliation: Department of Surgery, Nara Medical University, Kashihara, Nara, Japan.
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Nakajima
authors.affiliation: Department of Surgery, Kansai Medical University, Hirakata, Osaka, Japan.
authors.forename: Masanori
authors.initials: M
authors.lastname: Kon
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002214:Capsules; D016022:Case-Control Studies; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D065626:Non-alcoholic Fatty Liver Disease / Q000209:etiology* / Q000517:prevention & control*; D010190:Pancreatic Neoplasms / Q000601:surgery; D016577:Pancreaticoduodenectomy / Q000009:adverse effects*; D020799:Pancrelipase / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D002214:Capsules; D003692:Delayed-Action Preparations; D005765:Gastrointestinal Agents; D020799:Pancrelipase
keywords: Nonalcoholic fatty liver disease; Pancreatoduodenectomy; Pancrelipase; Randomized controlled trial