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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006841
Receipt No. R000008090
Scientific Title Prospective study on the treatment effect of pancrelipase on non-alcoholic fatty liver disease after panreatic resection
Date of disclosure of the study information 2011/12/05
Last modified on 2012/11/13

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Basic information
Public title Prospective study on the treatment effect of pancrelipase on non-alcoholic fatty liver disease after panreatic resection
Acronym Prospective study on the effect of pancrelipase on non-alcoholic fatty liver disease after panreatic resection
Scientific Title Prospective study on the treatment effect of pancrelipase on non-alcoholic fatty liver disease after panreatic resection
Scientific Title:Acronym Prospective study on the effect of pancrelipase on non-alcoholic fatty liver disease after panreatic resection
Region
Japan

Condition
Condition Pancreatic tumor, Duodenal cancer, Bile duct cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the treatment effect of pancrealipase on the non-alcoholic fatty liver disease (NAFLD) after pancreatic resection
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement rate of NAFLD
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pancrealipase
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient with non-alcoholic fatty liver disease after pancreatoduodenectomy or total pancreatectomy
Key exclusion criteria 1) Patients with alcohol addict (>150g/week) after surgery
2) Obesity (BMI>30)
3) Patients with persistent hepatitis
4) Patients with the routine steroid of use
5) Patients with fatty liver disease before surgery
6) Allergy in porcine protein or Digestive enzymes
7) Severe co-morbid diseases
8) Patients with past drug dependence
9) Pregnancy or insufficient contraception
10) Patients with acute pancreatitis and ileus
11) Patients with chronic pancreatitis
12) Malabsorption due to causes other than pancreatic diseases
13) Patients seems inadequate for this study by investigator(s)
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Sho
Organization Nara Medical University Hospital
Division name Department of Surgery
Zip code
Address 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Nara Medical University Hospital
Division name Department of Surgery
Zip code
Address
TEL
Homepage URL
Email m-sho@naramed-u.ac.jp

Sponsor
Institute Nara Medical University Hospital
Institute
Department

Funding Source
Organization Nara Medical University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 12 Month 05 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2011 Year 09 Month 24 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 12 Month 05 Day
Last modified on
2012 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008090

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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