UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008556 |
|---|---|
| Receipt number | 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 15:50:46 |
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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
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
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009611
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
