UMIN-CTR Clinical Trial

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