UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029908 |
|---|---|
| Receipt number | R000034164 |
| Scientific Title | Clinical studies of "the examination of the clinical benefit of the component nutrition agent which gives it to undernutrition and fatty liver caused after pancreatoduodenectomy" |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2017/11/10 09:53:26 |
* 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
Clinical studies of "the examination of the clinical benefit of the component nutrition agent which gives it to undernutrition and fatty liver caused after pancreatoduodenectomy"
Acronym
Clinical benefit of the component nutrition agent for undernutrition and the fatty liver after the pancreatoduodenectomy
Scientific Title
Clinical studies of "the examination of the clinical benefit of the component nutrition agent which gives it to undernutrition and fatty liver caused after pancreatoduodenectomy"
Scientific Title:Acronym
Clinical benefit of the component nutrition agent for undernutrition and the fatty liver after the pancreatoduodenectomy
Region
| Japan |
Condition
Condition
pancreatoduodenectomy case
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By the oral postoperative additive enteral nutrient the improvement of the undernutrition state and the decrease of the incidence of the fatty liver, the improvement of the accomplishment rate of the adjuvant chemotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the improvement of the undernutrition state : Alb,BTR,pre-alb
Key secondary outcomes
the decrease of the incidence of the fatty liver, the improvement of the accomplishment rate of the adjuvant chemotherapy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Pancreatoduodenectomy case
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)The patients who underwent pancreatoduodenectomy
2)The age at registration is less than 80 years old 20 years old or older
3)PS is 0-2
4)Enough oral intake
5)male and female
6)Written informed consent form is obtained from the patients
Key exclusion criteria
1)The patients with the disease with diabetes, chronic renal failure, heart failure limiting quantity of calorie, quantity of protein or a fluid volume
2)The pregnant patients
3)The patients who is judged to be in condition to lack in ability for agreement
4)The patients with the severe psychic disturbance
5)The patients who judged that it was inadequate so that a physician conducted this study safely
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | shuji Isaji |
Organization
Mie universuty
Division name
Department of Hepatobiliary Pancreas and Transplant Surgery
Zip code
Address
2-174 Edobashi, Tsu, Mie
TEL
059-232-1111
shujiisaji1@mac.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Kishiwada |
Organization
Mie universuty
Division name
Department of Hepatobiliary Pancreas and Transplant Surgery
Zip code
Address
2-174 Edobashi, Tsu, Mie
TEL
059-232-1111
Homepage URL
kishiwad@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie universuty
Department of Hepatobiliary Pancreas and Transplant Surgery
Institute
Department
Personal name
Funding Source
Organization
Mie universuty
Department of Hepatobiliary Pancreas and Transplant Surgery
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
2364
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
三重大学病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | 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
| 2012 | Year | 03 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 10 | Day |
Last modified on
| 2017 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034164
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
