UMIN-CTR Clinical Trial

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
Institute	National Cancer Center Hospital
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051964