UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038764 |
|---|---|
| Receipt number | 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 | 2021/06/05 16:20:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
m8827074@msic.med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
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
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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 24 | Day |
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
| 2021 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.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 |
