UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008346 |
|---|---|
| Receipt number | R000009615 |
| Scientific Title | Study of perioperative nutritional status improved by immunoenhancing enteral nutrients in patients who underwent pancreaticoduodenectomy. |
| Date of disclosure of the study information | 2012/07/04 |
| Last modified on | 2019/07/10 12:47:47 |
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Basic information
Public title
Study of perioperative nutritional status improved by immunoenhancing enteral nutrients in patients who underwent pancreaticoduodenectomy.
Acronym
Nutritional intervention trials in patients who underwent pancreaticoduodenectomy.
Scientific Title
Study of perioperative nutritional status improved by immunoenhancing enteral nutrients in patients who underwent pancreaticoduodenectomy.
Scientific Title:Acronym
Nutritional intervention trials in patients who underwent pancreaticoduodenectomy.
Region
| Japan |
Condition
Condition
Pancreatic cancer, Bile duct cancer, Duodenal cancer, Intraductal papillary mucinous neoplasm, Neuroendocrine tumor, Mesenchymal tumor
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the improvement of nutritional status and reduction of postoperative infectious complications by ingestion of immunoenhancing enteral nutrients in patients undergoing pancreaticoduodenectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body cell mass
Key secondary outcomes
Infectious complications, Other complications, Nutritional indexes, Length of hospital stay, Recurrence-free survival time, Overall survival
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
| Food |
Interventions/Control_1
Intake of immune-enhancing enteral nutrients from 2 weeks before surgery to 12 weeks after surgery. The dose of nutrients is approximately 600kcal per day.
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)Patients over the age of 20, and under the age of 80
2)Patients who will undergo Pancreaticoduodenectomy
3)Patients who fully understand the study procedures and consent the document voluntary after an adequate explanation
Key exclusion criteria
1)Patients who have active infection
2)Patients with milk allergy
3)Patients with ileus
4)Patients whose intestinal function is not the residual
5)Patients with advanced liver dysfunction or advanced renal dysfunction
6)Patients with abnormal glucose metabolism, such as severe diabetes
7)Patients with congenital disorders of amino acid metabolism
8)Patients who were deemed inappropriate for medical reasons
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Hasegawa |
Organization
The University of Tokyo
Division name
Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
Zip code
1138655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
0358143933
ichida-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Akihiko |
| Middle name | |
| Last name | Ichida |
Organization
The University of Tokyo
Division name
Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
Zip code
1138655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
ichida-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo, Hepato-biliary-pancreatic Surgery Division, Department of Surgery, 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
Clinical research support center, the university of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5800-8743
p1unit-office@umin.net
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
| 2012 | Year | 07 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
80
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
Completed
Date of protocol fixation
| 2012 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2012 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2012 | Year | 07 | Month | 04 | Day |
Last modified on
| 2019 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009615
