UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017858
Receipt number R000020692
Scientific Title Effectiveness of elemental diet for chylous ascites after pancreatoduodenectomy
Date of disclosure of the study information 2015/06/10
Last modified on 2015/06/10 13:32:16

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Basic information

Public title

Effectiveness of elemental diet for chylous ascites after pancreatoduodenectomy

Acronym

chylous ascites after pancreatoduodenectomy

Scientific Title

Effectiveness of elemental diet for chylous ascites after pancreatoduodenectomy

Scientific Title:Acronym

chylous ascites after pancreatoduodenectomy

Region

Japan


Condition

Condition

Pancreatic head tumor

Classification by specialty

Surgery in general Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the influence of elemental diet after pancreatoduodenectomy especially for chylous ascites

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Incidence of chylous ascites

Key secondary outcomes

Drain output
Total amount of administered elemental diet


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

Food

Interventions/Control_1

Administration of elemental diet on postoperative day 2 to 9 after pancreatoduodenectomy
300-600ml/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

Performance status 0-2
Tolerable to surgical resection
Patients from whom informed consent was obtained

Key exclusion criteria

Pregnant or braest feeding female
History of allergy for elemental diet
Sugar metabolic abnormality by severe diabetes mellitus or massive use of steroids
metabolic abnormality of amino acid
Not suitable patients judged by responsible doctors

Target sample size

105


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akio Saiura

Organization

Cancer Institute Hospital

Division name

Gastrointestinal surgery

Zip code


Address

3-8-31, Ariake, Koto, Tokyo

TEL

03-3520-0111

Email

saiura-tky@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akio Saiura

Organization

Cancer Institute Hospital

Division name

Gastrointestinal surgery

Zip code


Address

3-8-31, Ariake, Koto, Tokyo

TEL

03-3520-0111

Homepage URL


Email

saiura-tky@umin.ac.jp


Sponsor or person

Institute

Cancer Institute Hospital

Institute

Department

Personal name



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


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

2015 Year 06 Month 10 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

Completed

Date of protocol fixation

2012 Year 03 Month 29 Day

Date of IRB


Anticipated trial start date

2012 Year 04 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

2015 Year 06 Month 10 Day

Last modified on

2015 Year 06 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020692


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name