Unique ID issued by UMIN | UMIN000019817 |
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Receipt number | R000007508 |
Scientific Title | 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. |
Date of disclosure of the study information | 2015/11/17 |
Last modified on | 2019/04/01 18:16:50 |
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
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
Japan |
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.
Hepato-biliary-pancreatic surgery |
Malignancy
NO
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.
Efficacy
Incidence of post-opearative non-alcoholic fatty liver disease (within i year after PD)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
2
Treatment
Medicine |
Intervention group: Administration of Pancrelipase capsule with standard dose.
Control group: conventional administration of digestive enzymes
20 | years-old | <= |
Not applicable |
Male and Female
The patients with pancreatic cancerwho underwent pancreaticoduodenectomy (PD) or total pancreatectomy (TP) for pancreatic cancer.
The patients that the agreement was obtained in a document
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
80
1st name | |
Middle name | |
Last name | Sohei SATOI MD |
Kansai Medical University
Department of Surgery
2-3-1, Shin-machi, Hirakata-city, Osaka
072-804-0101
satoi@hirakata.kmu.ac.jp
1st name | |
Middle name | |
Last name | Sohei SATOI MD |
Kansai Medical University
Department of Surgery
2-3-1, Shin-machi, Hirakata-city, Osaka
072-804-0101
satoi@hirakata.kmu.ac.jp
Department of Surgery, Kansai Medical University
none
Self funding
NO
関西医科大学附属枚方病院 外科
2015 | Year | 11 | Month | 17 | Day |
Unpublished
Completed
2011 | Year | 09 | Month | 08 | Day |
2011 | Year | 11 | Month | 21 | Day |
2011 | Year | 11 | Month | 29 | Day |
2015 | Year | 09 | Month | 01 | Day |
2015 | Year | 11 | Month | 17 | Day |
2019 | Year | 04 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007508
Research Plan | |
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Registered date | File name |
2016/11/17 | Satoi_et_al-2016-Journal_of_Hepato-Biliary-Pancreatic_Sciences.pdf |
Research case data specifications | |
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Registered date | File name |
2016/11/17 | jhbp_14.pdf |
Research case data | |
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Registered date | File name |
2018/05/20 | Lipacreon RCT JHBPS 2016.pdf |