UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014887 |
|---|---|
| Receipt number | R000016760 |
| Scientific Title | Study of preoperative nutritional intervention in patients who underwent pancreaticoduodenectomy |
| Date of disclosure of the study information | 2014/08/19 |
| Last modified on | 2017/10/14 19:28:39 |
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Basic information
Public title
Study of preoperative nutritional intervention in patients who underwent pancreaticoduodenectomy
Acronym
Study of preoperative nutritional intervention in patients who underwent pancreaticoduodenectomy
Scientific Title
Study of preoperative nutritional intervention in patients who underwent pancreaticoduodenectomy
Scientific Title:Acronym
Study of preoperative nutritional intervention in patients who underwent pancreaticoduodenectomy
Region
| Japan |
Condition
Condition
pancreaticoduodenal carcinoma (pancreatic tumor, distal cholangiocarcinoma, ampullary carcinoma)
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the fast postoperative recovery and reduction of postoperative complications by preoperative nutrition support and shortening of preoperative fasting period in patients undergoing pancreaticoduodenectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the postoperative complications rate
Key secondary outcomes
first-year recurrence free survival, body weight, serum albumin, total lymphocyte count, total cholesterol, cholinesterase, CRP, HbA1c, insulin dose (if the patient use insulin injection)
Base
Study type
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
Intake of Elental(R) from 7-10 days before operation to the day before operation and oral carbohydrate-containing fluid in the operation 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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Patients with pancreaticoduodenal tumor
(pancreatic tumor, bile duct tumor, ampullary tumor)
(2)Patients who will undergo Pancreaticoduodenectomy
(3)Performance status: 0-2
(4)Patients who fully understand the study procedures and consent the document voluntary after an adequate explanation
(5)Patients who underwent pancreaticoduodenectomy before this study running (control arm)
Key exclusion criteria
(1) sever diabetes mellitus, disorder of carbohydrate metabolism due to high dose steroid
(2) disorder of amino acid metabolism
(3) allergy to Elental(R)
(4) Patients who are pregnant or hope to be pregnant
(5) Patients who offer discontinuation of the study
(6) Patients who are judged as inadequate to participate the study by the their doctors
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Itano |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
Shinanomachi 35, shinjuku-ku
TEL
03-3353-1211(ext62529)
contact@keio-hbpts.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minoru Kitago |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
Shinanomachi 35, shinjuku-ku
TEL
03-3353-1211(ext62529)
Homepage URL
contact@keio-hbpts.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Non
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
慶応義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 19 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | 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
| 2014 | Year | 08 | Month | 18 | Day |
Last modified on
| 2017 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016760
