UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055160 |
|---|---|
| Receipt number | R000063003 |
| Scientific Title | Taste Alteration Survey and Trace Elements (TASTE) in patients undergoing Pancreatoduodenectomy |
| Date of disclosure of the study information | 2024/08/06 |
| Last modified on | 2025/02/21 07:52:14 |
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Basic information
Public title
Taste Alteration Survey and Trace Elements (TASTE) in patients undergoing pancreatoduodenectomy
Acronym
TASTE-PD study
Scientific Title
Taste Alteration Survey and Trace Elements (TASTE) in patients undergoing Pancreatoduodenectomy
Scientific Title:Acronym
TASTE-PD study
Region
| Japan |
Condition
Condition
All tumors requiring pancreatoduodenectomy including biliary tract cancer, pancreatic cancer, and duodenal cancer.
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the frequency and characteristics of perioperative dysgeusia during hospitalization for pancreatoduodenectomy.
Basic objectives2
Others
Basic objectives -Others
To investigate the association between dysgeusia and serum levels of trace metal elements by comparing the patients with and without perioperative dysgeusia.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The frequency and characteristics of perioperative dysgeusia during hospitalization for pancreatoduodenectomy (between 2 days before surgery and postoperative day 21).
Key secondary outcomes
The frequency and characteristics of dysgeusia before surgery and on postoperative day 3, 7, 14, and 21.
Serum levels of trace metal elements before surgery and on postoperative day 1, 3, 7, 14, and 21 in the patients with and without perioperative dysgeusia.
(Trace metal elements include iron, zinc, magnesium, copper, inorganic phosphate, and calcium).
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
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(I) Patients who are aged 20-79 years.
(II) Patients who are able to provide written informed consent.
(III) Patients who are considered reliable in expressing their symptoms according to a questionnaire.
(IV) Patients who are scheduled to undergo PD.
(V) Patients who had undergone preoperative chemotherapy or had a history of gastrectomy will be also included.
Key exclusion criteria
(I) Patients with psychiatric diseases including dementia.
(II) Patients with liver cirrhosis.
(III) Patients with renal failure (creatinine over 2 mg/dL).
(IV) Patients with anemia (hemoglobin under 9.0 g/dL).
(V) Patients who are scheduled to undergo hepato-pancreatoduodenectomy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Teiichi |
| Middle name | |
| Last name | Sugiura |
Organization
Shizuoka Cancer Center
Division name
Division of Hepato-Biliary-Pancreatic Surgery
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-5222
t.sugiura@scchr.jp
Public contact
Name of contact person
| 1st name | Katsuhisa |
| Middle name | |
| Last name | Ohgi |
Organization
Shizuoka Cancer Center
Division name
Division of Hepato-Biliary-Pancreatic Surgery
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-5222
Homepage URL
ka.ogi@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
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
Shizuoka Cancer Center
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
Tel
055-989-5222
rinsho_office@scchr.jp
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
| 2024 | Year | 08 | Month | 06 | 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
100
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Between April 2021 and September 2022, 100 patients fulfilled the inclusion criteria and participated in the study. The questionnaire was distributed to all patients following administration. Patients were asked to complete the questionnaires on the day before surgery and on postoperative days 3, 7, 14, and 21 and then place the sheets into an opaque file to blind them to all medical workers. Blood samples were collected on the day before surgery and on postoperative days 1, 3, 7, 14, and 21. General biochemical variables and trace metal elements, including iron, zinc, magnesium, copper, inorganic phosphate, and calcium, were measured.
Management information
Registered date
| 2024 | Year | 08 | Month | 05 | Day |
Last modified on
| 2025 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063003
