UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031142 |
|---|---|
| Receipt number | R000035575 |
| Scientific Title | The effect of perioperative oral management on the outcomes in patients diagnosed as sarcopenia with hepato-biliary-pancreatic cancers. |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2020/08/12 11:52:49 |
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Basic information
Public title
The effect of perioperative oral management on the outcomes in patients diagnosed as sarcopenia with hepato-biliary-pancreatic cancers.
Acronym
OMSA-HBP
Scientific Title
The effect of perioperative oral management on the outcomes in patients diagnosed as sarcopenia with hepato-biliary-pancreatic cancers.
Scientific Title:Acronym
OMSA-HBP
Region
| Japan |
Condition
Condition
Liver cancer, biliary tract cancer, pancreatic cancer
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of perioperative oral management on the outcomes in patients diagnosed as sarcopenia with hepato-biliary-pancreatic cancers.
Basic objectives2
Others
Basic objectives -Others
Efficacy of oral management
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative complication
Hospital death
The days of Hospitalization stay after the operation
Key secondary outcomes
Overall survival at one year and two yaers after the operation.
Recurrence free survival at one year and two yaers after the operation.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Perioperative oral management
Interventions/Control_2
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
The patients diagnosed as sarcopenia with hepato-biliary-pancreatic cancers who will undergo the operation.
Key exclusion criteria
The patients who have allergies for
contrast media of CT or cannot take the CT examination because of severe renal dysfuncion.
The patients with more than 2 in perfoemance status
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Etsuro |
| Middle name | |
| Last name | Hatano |
Organization
Hyogo College of Medicine
Division name
The department of Hepato-Bliary-Pncreatic surgery
Zip code
6638501
Address
1-1, Mukogawa town Nishinomiya city, Hyogo prefecture, Japan
TEL
0798-45-6582
shatano@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Ikuo |
| Middle name | |
| Last name | Nakamura |
Organization
Hyogo College of Medicine
Division name
The department of Hepato-Bliary-Pncreatic surgery
Zip code
6638501
Address
1-1, Mukogawa town Nishinomiya city, Hyogo prefecture, Japan
TEL
0798-45-6582
Homepage URL
http://www.hosp.hyo-med.ac.jp/
shatano@hyo-med.ac.jp
Sponsor or person
Institute
The department of Hepato-Bliary-Pncreatic surgery, Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Kitano Hostital
Osaka Red Cross Hospital
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Hyogo college of Medicine
Address
1-1, Mukogawa town Nishinomiya city, Hyogo prefecture, Japan
Tel
0798456582
rinri@hyo-med.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
兵庫医科大学 Hyogo College of Medicine
北野病院 Kitano Hospital
大阪赤十字病院 Osaka Red Cross Hospital
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.hosp.hyo-med.ac.jp/
Publication of results
Unpublished
Result
URL related to results and publications
http://www.hosp.hyo-med.ac.jp/
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
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 05 | Day |
Last modified on
| 2020 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035575
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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