UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059195 |
|---|---|
| Receipt number | R000060234 |
| Scientific Title | Optimal anesthesia for bladder cancer surgery using 5-aminolevulinic acid |
| Date of disclosure of the study information | 2025/09/25 |
| Last modified on | 2025/09/25 21:31:16 |
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Basic information
Public title
Optimal anesthesia for bladder cancer surgery using 5-aminolevulinic acid
Acronym
Optimal anesthesia for bladder cancer surgery using 5-aminolevulinic acid
Scientific Title
Optimal anesthesia for bladder cancer surgery using 5-aminolevulinic acid
Scientific Title:Acronym
Optimal anesthesia for bladder cancer surgery using 5-aminolevulinic acid
Region
| Japan |
Condition
Condition
bladder cancer
Classification by specialty
| Urology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigation of anesthesia methods used in bladder cancer surgery that can alleviate hypotension caused by 5-aminolevulinic acid.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency and severity of intraoperative hypotension
Key secondary outcomes
Frequency of Use of Hypertensive Drugs
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We will review the medical records and anesthesia records preserved at our hospital from January 1, 2018, to December 31, 2024, for patients who underwent bladder cancer surgery using 5-aminolevulinic acid (5-ALA) during this period. From these records, we will extract data on anesthesia methods and intraoperative blood pressure values to detect the frequency and severity of intraoperative hypotension. Patients will be categorized into three groups based on anesthesia method: general anesthesia, general anesthesia with remimazolam, and spinal anesthesia. The extracted hypotensive events will then be analyzed within each group to evaluate the primary and secondary endpoints.
Key exclusion criteria
non
Target sample size
425
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Katsumata |
Organization
Kochi University
Division name
Department of Anesthesiology and Intensive Care Medicine, Kochi medical school
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku City, Kochi Prefecture, Japan
TEL
088-880-2471
katsu1206@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Katsumata |
Organization
Kochi University
Division name
Department of Anesthesiology and Intensive Care Medicine, Kochi medical school
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku City, Kochi Prefecture, Japan
TEL
088-880-2471
Homepage URL
katsu1206@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Funding Source
Organization
non
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
Ethical Review Board of Kochi medical school
Address
Kohasu, Oko-cho, Nankoku City, Kochi Prefecture, Japan
Tel
088-880-2180
rinri21@kochi-u.ac.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
| 2025 | Year | 09 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective observational study of patients undergoing transurethral resection of bladder tumor (TURBT) with 5-aminolevulinic acid (5-ALA) at our institution
Management information
Registered date
| 2025 | Year | 09 | Month | 25 | Day |
Last modified on
| 2025 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060234
