UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027632 |
|---|---|
| Receipt number | R000031633 |
| Scientific Title | A feasibility study of perioperative administration of immunoenhancing enteral nutrients combined with pancrelipase in patients with pancreatoduodenectomy for pancreatic cancer |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2018/01/31 22:34:52 |
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Basic information
Public title
A feasibility study of perioperative administration of immunoenhancing enteral nutrients combined with pancrelipase in patients with pancreatoduodenectomy for pancreatic cancer
Acronym
A feasibility study of perioperative administration of immunoenhancing enteral nutrients combined with pancrelipase in patients with pancreatoduodenectomy for pancreatic cancer
Scientific Title
A feasibility study of perioperative administration of immunoenhancing enteral nutrients combined with pancrelipase in patients with pancreatoduodenectomy for pancreatic cancer
Scientific Title:Acronym
A feasibility study of perioperative administration of immunoenhancing enteral nutrients combined with pancrelipase in patients with pancreatoduodenectomy for pancreatic cancer
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| 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 complications by ingestion of immunoenhancing enteral nutrients and pancrelipase in patients undergoing pancreaticoduodenectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment completion rate of preoperative ingestion of immunoenhancing enteral nutrients and pancrelipase
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
1, Administration of immune-enhancing enteral nutrients from 2 weeks before surgery to 3 weeks after surgery. The dose of nutrients depends on the phase from 480kcal to 960kcal,
2. Administration of pancrelipase from postoperative day 1 to 21. The dose of pancrelipase is 1800mg 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with pancreatic cancer
2. Patients who will undergo Pancreaticoduodenectomy
3. ECOG-PS 0 or 1
4. Patients who can intake orally
5. Patients who fully understand the study procedures and consent the document voluntary after an adequate explanation
Key exclusion criteria
1. Patients with active double cancer
2. Patients who have active infection
3. Patients who need to restrict food or water intake
4. Patients with milk or soy allergy
5. Patients with pancrelipase allergy
6. Patients with pork protein allergy
7. Patients with ileus
8. Patients with advanced liver dysfunction or advanced renal dysfunction
9. Patients with abnormal glucose metabolism, such as severe diabetes
10. Patients with congenital disorders of amino acid metabolism
11. Patients with pregnancy
12. Patients who were deemed inappropriate for medical reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Kodera |
Organization
Nagoya University, Graduate School of Medicine
Division name
Gastroenterorogical Surgery
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya city
TEL
052-744-2253
ykodera@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Suguru Yamada |
Organization
Nagoya University, Graduate School of Medicine
Division name
Gastroenterorogical Surgery
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya city
TEL
052-744-2253
Homepage URL
suguru@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University, Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 07 | 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
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | 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
| 2017 | Year | 06 | Month | 04 | Day |
Last modified on
| 2018 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031633
| 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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