UMIN-CTR Clinical Trial

Basic information
Public title	Phase 2 trial to evaluate immunomodulating diet enriched with whey peptide by perioperative administration in pancreatoduodenectomy for hepato-biliary-pancreatic malignancy
Acronym	NEW-PASSO
Scientific Title	Phase 2 trial to evaluate immunomodulating diet enriched with whey peptide by perioperative administration in pancreatoduodenectomy for hepato-biliary-pancreatic malignancy
Scientific Title:Acronym	NEW-PASSO
Region	Japan

Condition
Condition	pancreas cancer,bile duct cancer, ampullary cancer
Classification by specialty	Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate whether perioperative administration of immunomodulating diet enriched with whey peptide could reduce the infectious and non-infectious complication after pancreaticoduodenectomy for hepato-biliary-pancreatic malignancy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	incidence of infectious/non-infectious complication
Key secondary outcomes	length of post-operative hospital stay mortality rate serum cytokine level etc.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Food
Interventions/Control_1	Intervention:The volume of administrated immunomodulating diet is 600ml/day.
Interventions/Control_2	Intervention:The volume of administrated standard diet is 600ml/day.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with pancreas,bile duct and ampullary cancer who will undergo pancreatoduodenectomy
Key exclusion criteria	Patients who cannot tolerate enteral nutrition and who have severe heart, respiratory, renal,liver dysfunction and severe malnutrition are excluded.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Junji Yamamoto
Organization	National Defense Medical College Hospital
Division name	Department of Surgery
Zip code
Address	3-2, Namiki, Tokorozawa, Saitama
TEL	04-2995-1211
Email	jyamamot@ndmc.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tomoyuki Moriya
Organization	National Defense Medical College Hospital
Division name	Department of Surgery
Zip code
Address	3-2, Namiki, Tokorozawa, Saitama
TEL	04-2995-1211
Homepage URL
Email	tmoriya@ndmc.ac.jp

Sponsor
Institute	Department of Surgery, National Defense Medical College
Institute
Department

Funding Source
Organization	National Defense Medical College
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2013 Year 12 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	2012 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date	2012 Year 05 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	2013 Year 11 Month 07 Day
Last modified on	2013 Year 11 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014243

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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