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.
- 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.
- Registration Number
- JPRN-UMIN000019817
- Lead Sponsor
- Department of Surgery, Kansai Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of post-opearative non-alcoholic fatty liver disease (within i year after PD)
- Secondary Outcome Measures
Name Time Method