UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036511 |
|---|---|
| Receipt number | R000041594 |
| Scientific Title | Prospective study on the usefulness of K-2S plus as as enteral nutrients after pancreatoduodenectomy |
| Date of disclosure of the study information | 2019/05/07 |
| Last modified on | 2019/10/28 09:50:43 |
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Basic information
Public title
Prospective study on the usefulness of K-2S plus as as enteral nutrients after pancreatoduodenectomy
Acronym
Prospective study on the usefulness of K-2S plus as as enteral nutrients after pancreatoduodenectomy
Scientific Title
Prospective study on the usefulness of K-2S plus as as enteral nutrients after pancreatoduodenectomy
Scientific Title:Acronym
Prospective study on the usefulness of K-2S plus as as enteral nutrients after pancreatoduodenectomy
Region
| Japan |
Condition
Condition
Patients who undergo pancreatoduodenectomy for peri-pancreatic tumors such as pancreatic cancers or lower bile duct cancers
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study to compare prospectively the efficacy of K-2S plus as enteral nutrients after pancreatoduodenectomy to that of ELENTAL.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation frequency
Fecal condition (Bristol scale)
Key secondary outcomes
Weight loss rate
Lymphocyte count and reduction rate
Serum albumin level and reduction rate
Serum prealbumin (transthyretin) levels and reduction rates
Postoperative complication rate (Clavian-Dindo IIIa or more)
Enteral nutrition protocol completion rate
Enteral nutrition protocol total administered calories
Total calories required after enteral feeding protocol
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
Patients who will undergo PD will be prospectively registered and assigned to K-2S plus group from patients who have started registration. When the number of cases in the K-2S plus group reaches 20, the assignment to the K-2S plus group ends.
Interventions/Control_2
Cases in which IC of K-2S plus administration can not be obtained will be assigned to the Elental group. After the K-2S plus group reached 20 cases, all were assigned to the Elenthal group, and when the Elental group reached 20 cases, the entire assignment was completed.
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) Cases where the age of registration date is over 20 years old
(2) PS (ECOG) 0 or 1 case
(3) Cases that meet all the following conditions
For all test items, the latest value is used within 14 days before surgery (a test on the same day two weeks before the registration date is acceptable).
1) White blood cells> or more 4,000 and < or less 12,000.
2) Neutrophil> or more 2,000.
3) Platelets> or more 100,000.
4) Hemoglobin> or more 8.0.
5) AST< or less 100.
6) ALT< or less 100.
7) Total bilirubin< or less 1.2.
8) Serum creatinine< or less 1.2.
(4) Cases that can be taken orally (Dysphagia score< or less 1).
Key exclusion criteria
(1) Patients who are contraindicated with K-2S plus or Erental
1) A case with allergies to eggs, dairy products and soy
2) A case with hypersensitivity to K-2S plus
3) A case with hypersensitivity to Ellenthal
4) A case with amino acid metabolism disorder
(2) Cases with active bacterial and fungal infections (cases with fever above 38 degree and cases where bacterial infection has been shown by imaging or bacteriological examination).
(3) A case that is complicated by psychosis or psychiatric symptoms and difficult to participate in this study.
(4) Cases that the study responsible (share) physician judged inappropriate for this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hideo |
| Middle name | |
| Last name | Baba |
Organization
Graduate School of Medical Sciences,
Kumamoto University
Division name
Department of Gastroenterological Surgery
Zip code
860-8556
Address
1-1-1, Honjo, Chuo-ku, Kumamoto
TEL
096-373-5211
hdobaba@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yo-ichi |
| Middle name | |
| Last name | Yamashita |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Department of Gastroenterological Surgery
Zip code
860-8556
Address
1-1-1, Honjo, Chuo-ku, Kumamoto
TEL
096-373-5211
Homepage URL
y-yama@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
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
Kumamoto University Hospital
Address
1-1-1, Honjo, Chuo-ku, Kumamoto
Tel
096-373-5966
byi-senshin@jimu.kumamoto-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
| 2019 | Year | 05 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2019 | Year | 04 | Month | 15 | Day |
Last modified on
| 2019 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041594
