Phase II randomized clinical trial for the purpose of examining the protective efficacy of the non-alcoholic fatty liver development by pancrelipase preparation being given for pancreatic cancer patients who underwent pancreaticoduodenectomy or total pancreatectomy. - Phase II randomized clinical trial about the non-alcoholic fatty liver development prevention with the pancrelipase preparation administration

Department of Surgery, Kansai Medical University0 sites80 target enrollmentNovember 17, 2015

Overview

Phase: 未知
Intervention: Not specified
Conditions: To assume the decreased rate of post-operative non-alcoholic fatty liver incidence in pancreatic cancer patients with the prophylactic administration of the pancrelipase preparation.
Sponsor: Department of Surgery, Kansai Medical University
Enrollment: 80
Status: Completed
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

November 17, 2015

End Date

September 1, 2015

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Department of Surgery, Kansai Medical University

•1 The patients who had a diagnosis of non alcoholic fatty liver by perioperative liver biopsy 2 The patients who cannot do initiation of the pancrelipase preparation even if it passes for two months after surgery 3 Alcohol common custom drinking career after surgery 4 Severe obesity BMI\>30 5 The patients with the persistent infection of the hepatitis virus 6 The patients who receive steroid treatment 7 The patients with the preoperative fatty liver 8 patients with the allergy to swine protein or digestive enzymes preparation 9 The patients with a grave cardiovascular system, a respiratory system, a digestive system, an urinary system or a mind, the neurological disease 10 The patients with a history of the drug abuse 11 During the pregnancy or the patients nursing and the patients who may be pregnant 12 Patients with acute pancreatitis and patients with bowel obstruction 13 the patients of the acute advanced stage in patients with chronic pancreatitis 14 The patients with the factor that may affect other treatment outcomes and the patients who judged it when a clinical trial responsibility doctor or a clinical trial allotment doctor should not participate in a clinical trial 15 The patients who cannot do it of the self judgment