UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008346
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email ichida-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo, Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009615

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.