UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027682 |
|---|---|
| Receipt number | R000031695 |
| Scientific Title | Effectiveness of preoperative nutrition and rehabilitation therapy for sarcopenia in patients undergoing hepatobiliary and pancreatic surgery |
| Date of disclosure of the study information | 2017/06/09 |
| Last modified on | 2021/01/10 22:16:31 |
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Basic information
Public title
Effectiveness of preoperative nutrition and rehabilitation therapy for sarcopenia in patients undergoing hepatobiliary and pancreatic surgery
Acronym
Effectiveness of preoperative nutrition and rehabilitation for sarcopenia
Scientific Title
Effectiveness of preoperative nutrition and rehabilitation therapy for sarcopenia in patients undergoing hepatobiliary and pancreatic surgery
Scientific Title:Acronym
Effectiveness of preoperative nutrition and rehabilitation for sarcopenia
Region
| Japan |
Condition
Condition
HCC,biliary cancer, pancreatic cancer, metastatic liver cancer, benign disease
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influence of preoperative nutrition and prehabilitation therapy for sarcopenia on hepatectomy and pancreatectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
skeletal muscle mass
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Nutrition
Branched-chain amino acid supplementation
Aminoleban EN powder mix
Livact
The patients in the BCAA supplementation groups took one sachet of Aminoleban and/or Livact three times daily after meals.
Enteral nutrition product
Ensure Liquid
Interventions/Control_2
Rehabilitation
Resistance exercises
Theraband resistance training
Inspiratory muscle strengthening
Aerobic exercises
Walking
Treadmill
Ergometer
Ascending/descending stairs
Interventions/Control_3
Nutrition and rehabilitation
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) The patient with a malignant tumor (hepatocellular carcinoma, metastatic liver cancer, biliary cancer, pancreatic cancer) or benign hepatobiliary and pancreatic disease.
2) Hepatectomy or pancreatectomy planted patient.
3) 20 years or older.
4) Agreement is provided in a document about the participation of this study.
The patients who underwent hepatectomy or pancreatectomy.
he primary diseases were categorized as benign disease (n = 6; 7%), HCC (n = 21; 26%), biliary cancer (n = 9; 11%), pancreatic cancer (n = 13; 16%), metastatic liver cancer 27 (33%), and others (n = 6; 7%).
Key exclusion criteria
1) The patient who have active diseases other than resection planned tumor
2) The patient who cannot walk
3) The patient who cannot eat
4) The patient who was judged to be inappropriate
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Araki |
Organization
Integrative Center of General Surgery, Gunma University Hospital
Division name
Hepatobiliary and Pancreatic Surgery
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi Gunma 371-8511, Japan
TEL
027-220-8229
karaki@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Tsukagoshi |
Organization
Integrative Center of General Surgery, Gunma University Hospital
Division name
Hepatobiliary and Pancreatic Surgery
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi Gunma 371-8511, Japan
TEL
027-220-8229
Homepage URL
marikot@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital Clinical Research Review Board
Address
3-39-15 Showa-machi, Maebashi Gunma 371-8511, Japan
Tel
026-220-8740
r_taguchi@gunma-u.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
| 2017 | Year | 06 | Month | 09 | 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
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2021 | 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
| 2017 | Year | 06 | Month | 08 | Day |
Last modified on
| 2021 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031695
| 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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