UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045514
Receipt number R000051964
Scientific Title Influence of Gustatory Changes and Anxiety/Depression on Prolonged Malnutrition after Major HBP Surgery
Date of disclosure of the study information 2021/09/18
Last modified on 2021/09/18 14:00:40

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Basic information

Public title

Influence of Gustatory Changes and Anxiety/Depression on Prolonged Malnutrition after Major HBP Surgery

Acronym

GustAD study

Scientific Title

Influence of Gustatory Changes and Anxiety/Depression on Prolonged Malnutrition after Major HBP Surgery

Scientific Title:Acronym

GustAD study

Region

Japan


Condition

Condition

patients who are undergoing maror hepatectomy or pancreaticoduodenectomy

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Evaluation of perioperative malnutrition using gustatory and anxious assessment questionnaires

Basic objectives2

Others

Basic objectives -Others

Evaluation of perioperative malnutrition using gustatory and anxious assessment questionnaires

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Association between questionaries outcome and malnutrition

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who are undergoing major hepatectomy or pancreaticoduodenectomy

Key exclusion criteria

patients who did not agree with the study

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Takeshi
Middle name
Last name Takamoto

Organization

National Cancer Center Hospital

Division name

Division of hepatobiliary pancreatic surgery

Zip code

1040045

Address

5-1-1, Tsukiji, Chuo-ku, Tokyo

TEL

0335422511

Email

takamoto@nifty.com


Public contact

Name of contact person

1st name Takeshi
Middle name Takamoto
Last name Takamoto

Organization

National Cancer Center Hospital

Division name

Hepatibilliary Pancreatic Surgery

Zip code

1040045

Address

5-1-1, Tsukiji, Chuo-ku, Tokyo

TEL

0335422511

Homepage URL


Email

takamoto@nifty.com


Sponsor or person

Institute

National Cancer Center Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Cancer Center Hospital

Address

5-1-1, Tsukiji, Chuo-ku, Tokyo

Tel

0335422511

Email

takamoto@nifty.com


Secondary IDs

Secondary IDs

YES

Study ID_1

2020-261

Org. issuing International ID_1

2020-261

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2021 Year 09 Month 18 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

2020 Year 09 Month 18 Day

Date of IRB

2020 Year 09 Month 10 Day

Anticipated trial start date

2020 Year 09 Month 18 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2021 Year 09 Month 18 Day

Last modified on

2021 Year 09 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051964


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name