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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038764
Receipt No. R000044189
Scientific Title Postoperative obesity treatment for obese patients with hepatocellular carcinoma prevents hepatocarcinogenesis: Special reference with bacterial flora
Date of disclosure of the study information 2020/01/01
Last modified on 2019/12/03

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Basic information
Public title Postoperative obesity treatment for obese patients with hepatocellular carcinoma prevents hepatocarcinogenesis: Special reference with bacterial flora
Acronym Clarification of hepatocarcinogenesis in obese patients
Scientific Title Postoperative obesity treatment for obese patients with hepatocellular carcinoma prevents hepatocarcinogenesis: Special reference with bacterial flora
Scientific Title:Acronym Clarification of hepatocarcinogenesis in obese patients
Region
Japan

Condition
Condition Obese patients with hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We investigated obesity treatment prevents hepatocarcinogenesis after hepatic resection in obese patients with association of change in bacterial flora with hepatocarcinogenesis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Hepatocarcinogenesis within 2 years after hepatic resection
Key secondary outcomes Bacterial flora
Serum diamine oxidase
Fecal IgA
Hepatic fibrosis

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 For obese patients who schedule hepatectomy for initial hepatocellular carcinoma

Obesity treatment group: diet 25 Kcal/Kg/d for 6 months
Interventions/Control_2 For obese patients who schedule hepatectomy for initial hepatocellular carcinoma

Control group:diet 30 Kcal/Kg/d for 6 months
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) obese patients (BMI 30Kg/m2 or more) who schedule hepatectomy for initial hepatocellular carcinoma
2) Age of 20 years or older
Key exclusion criteria 1) Patients with BMI <30Kg/m2 who schedule hepatectomy for initial hepatocellular carcinoma
2) Recurrence of hepatocellular carcinoma
3) Age <20 years old
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Tanaka
Middle name
Last name Shogo
Organization Osaka City University
Division name Department of Hepato-Biliary-Pancreatic Surgery
Zip code 5458585
Address 1-4-3 Asahimachi, Abeno-ku, Osaka, Japan
TEL 0666453841
Email m8827074@msic.med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name Tanaka
Middle name
Last name Shogo
Organization Osaka City University
Division name Department of Hepato-Biliary-Pancreatic Surgery
Zip code 5458585
Address 1-4-3 Asahimachi, Abeno-ku, Osaka, Japan
TEL 0666453841
Homepage URL
Email m8827074@msic.med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology, Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Osaka City University
Address 1-4-3 Asahimachi, Abeno-ku, Osaka, Japan
Tel 0666453841
Email m8827074@msic.med.osaka-cu.ac.jp

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
2020 Year 01 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2020 Year 01 Month 01 Day
Last follow-up date
2024 Year 03 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
2019 Year 12 Month 03 Day
Last modified on
2019 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044189

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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