Volume 23, Issue 3 pp. 167-173
Original Article

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

Sohei Satoi

Corresponding Author

Sohei Satoi

Department of Surgery, Kansai Medical University, Hirakata, Osaka, Japan

Correspondence to: Sohei Satoi, Department of Surgery, Kansai Medical University, 2–5-1 Shin-machi, Hirakata, Osaka 573–1010, Japan.

Email: [email protected]

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Masayuki Sho

Masayuki Sho

Department of Surgery, Nara Medical University, Kashihara, Nara, Japan

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Hiroaki Yanagimoto

Hiroaki Yanagimoto

Department of Surgery, Kansai Medical University, Hirakata, Osaka, Japan

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Tomohisa Yamamoto

Tomohisa Yamamoto

Department of Surgery, Kansai Medical University, Hirakata, Osaka, Japan

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Takahiro Akahori

Takahiro Akahori

Department of Surgery, Nara Medical University, Kashihara, Nara, Japan

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Shoichi Kinoshita

Shoichi Kinoshita

Department of Surgery, Nara Medical University, Kashihara, Nara, Japan

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Minako Nagai

Minako Nagai

Department of Surgery, Nara Medical University, Kashihara, Nara, Japan

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Satoshi Hirooka

Satoshi Hirooka

Department of Surgery, Kansai Medical University, Hirakata, Osaka, Japan

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So Yamaki

So Yamaki

Department of Surgery, Kansai Medical University, Hirakata, Osaka, Japan

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Satoshi Nishiwada

Satoshi Nishiwada

Department of Surgery, Nara Medical University, Kashihara, Nara, Japan

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Hironori Ryota

Hironori Ryota

Department of Surgery, Kansai Medical University, Hirakata, Osaka, Japan

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Naoya Ikeda

Naoya Ikeda

Department of Surgery, Nara Prefectural Seiwa Medical Center, Nara City, Nara, Japan

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Yoshiyuki Nakajima

Yoshiyuki Nakajima

Department of Surgery, Nara Medical University, Kashihara, Nara, Japan

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Masanori Kon

Masanori Kon

Department of Surgery, Kansai Medical University, Hirakata, Osaka, Japan

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First published: 08 January 2016
Citations: 16
Sohei Satoi and Masayuki Sho contributed equally to this work.

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.

Conclusion

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).

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