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Recruitment status Terminated
Unique ID issued by UMIN UMIN000008556
Receipt No. R000009611
Scientific Title Prospective study of the efficacy of pancreatic enzyme replacement therapy for non-alcoholic fatty liver disease after pancreatectomy
Date of disclosure of the study information 2012/07/30
Last modified on 2019/10/30

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Basic information
Public title Prospective study of the efficacy of pancreatic enzyme replacement therapy for non-alcoholic fatty liver disease after pancreatectomy
Acronym Prospective study of the efficacy of pancreatic enzyme replacement therapy for non-alcoholic fatty liver disease after pancreatectomy
Scientific Title Prospective study of the efficacy of pancreatic enzyme replacement therapy for non-alcoholic fatty liver disease after pancreatectomy
Scientific Title:Acronym Prospective study of the efficacy of pancreatic enzyme replacement therapy for non-alcoholic fatty liver disease after pancreatectomy
Region
Japan

Condition
Condition Pancreatic or biliary tract disease required pancreatectomy
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the efficacy of pancreatic enzyme replacement therapy for non-alcoholic fatty liver disease after pancreatectomy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes The incidence of non-alcoholic fatty liver disease three months after surgery
Key secondary outcomes The incidence of exocrine pancreatic insufficiency three months after surgery

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pancreatic enzyme replacement therapy after pancreatectomy
Interventions/Control_2 Control group (no treatment)
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 Patients with pancreatic or biliary tract disease requiring pancreatectomy
Key exclusion criteria 1.Patients with acute ischemic heart disease
2.Patients with preoperative fatty liver/liver cirrhosis, viral hepatitis or alcoholic liver disease
3.Patients with heavy use of alcohol
4.Patients with interstitial pneumonia or fibroid lung who require oxygen administration
5.Patients with chronic renal failure requiring dialysis
6.Patients with other malignant disease
7.Patients who have a hypersensitivity to Lipacreon® or pig protein
8.Patients who are diagnosed to be ineligible by the investigator
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiaki Murakami
Organization Hiroshima University Hospital
Division name Gastrointestinal Surgery
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kenichiro Uemura
Organization Hiroshima University Hospital
Division name Gastrointestinal Surgery
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-5216
Homepage URL
Email

Sponsor
Institute Hiroshima University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
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 広島大学病院(広島県)

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 30 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 Terminated
Date of protocol fixation
2012 Year 05 Month 25 Day
Date of IRB
2012 Year 07 Month 25 Day
Anticipated trial start date
2012 Year 07 Month 30 Day
Last follow-up date
2019 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 07 Month 28 Day
Last modified on
2019 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009611

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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