UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003940 |
|---|---|
| Receipt number | R000004741 |
| Scientific Title | A randomized controlled trial assessing the influence of dietary intake on healing process of pancreatic fistula following pancreatectomy |
| Date of disclosure of the study information | 2010/07/23 |
| Last modified on | 2018/07/25 14:52:03 |
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Basic information
Public title
A randomized controlled trial assessing the influence of dietary intake on healing process of pancreatic fistula following pancreatectomy
Acronym
A randomized controlled trial assessing the influence of dietary intake on healing process of pancreatic fistula following pancreatectomy
Scientific Title
A randomized controlled trial assessing the influence of dietary intake on healing process of pancreatic fistula following pancreatectomy
Scientific Title:Acronym
A randomized controlled trial assessing the influence of dietary intake on healing process of pancreatic fistula following pancreatectomy
Region
| Japan |
Condition
Condition
Pancreatic disease or periampullary disease
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the influence of dietary intake on healing process of pancreatic fistula following pancreatectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Duration of pancreatic drainage
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Dietary intake
Interventions/Control_2
No dietary intake
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
1) Patients who have postoperative pancreatic fistulae following A) pancreatoduodenectomy (modified Child reconstruction) or B) distal pancreatectomy for pancreatic diseases or periampullary diseases
2) written informed consent
Key exclusion criteria
1) regular use of medicine that may possibly affect the healing process, e.g. adrenal corticosteroid
2) hemodialysis
3) other reconstructive methods, e.g. pancreatogastrostomy, Imanaga method, and so on
4) patients judged inappropriate for the study by the physicians
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akimasa Nakao |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Surgery II (Gastroenterological surgery)
Zip code
Address
65,Tsurumai-cho,Showa-ku,Nagoya,Aichi
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Fujii |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Surgery II (Gastroenterological surgery)
Zip code
Address
TEL
Homepage URL
fjt@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Surgery II (Gastroenterological surgery), Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2010 | Year | 07 | Month | 23 | 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
Main results already published
Date of protocol fixation
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 07 | Month | 23 | Day |
Last modified on
| 2018 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004741
