UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060210 |
|---|---|
| Receipt number | R000068839 |
| Scientific Title | Investigation into the incidence of hypotension during trensurethral resection of bladder tumor using Aminolevulinic Acid Hydrochloride |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/12/26 11:07:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation into the incidence of hypotension during trensurethral resection of bladder tumor using Aminolevulinic Acid Hydrochloride
Acronym
Investigation into the incidence of hypotension during trensurethral resection of bladder tumor using Aminolevulinic Acid Hydrochloride
Scientific Title
Investigation into the incidence of hypotension during trensurethral resection of bladder tumor using Aminolevulinic Acid Hydrochloride
Scientific Title:Acronym
Investigation into the incidence of hypotension during trensurethral resection of bladder tumor using Aminolevulinic Acid Hydrochloride
Region
| Japan |
Condition
Condition
Bladder cancer
Classification by specialty
| Urology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Hypotension is a side effect of transurethral resection of bladder tumors using photodynamic diagnosis with 5-aminolevulinic acid hydrochloride (5-ALA preparation, trade name: Alagrio Granules, 1.5g sachets). However, the mechanism of its occurrence remains largely unclear. This study investigates the relationship between the onset of hypotension and the blood concentration of vasodilator substances in patients undergoing PDD-TUR-Bt using 5-ALA.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure readings 5 minutes after anesthesia initiation
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
| 18 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients undergoing TUR-bt with spinal subarachnoid anesthesia starting January 1, 2025
2. Patients for whom written consent to participate in this study is obtained
Key exclusion criteria
1. Patients from whom consent cannot be obtained
2. Other patients deemed unsuitable for the study at the physician's discretion
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Arisa |
| Middle name | |
| Last name | Tanaka |
Organization
Gifu University Hospital
Division name
Department of Anesthesiology & Pain Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu City, Gifu Prefecture
TEL
058-230-6000
tanaka.arisa.p0@f.gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Arisa |
| Middle name | |
| Last name | Tanaka |
Organization
Gifu University Hospital
Division name
Department of Anesthesiology & Pain Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu City, Gifu
TEL
058-230-6000
Homepage URL
tanaka.arisa.p0@f.gifu-u.ac.jp
Sponsor or person
Institute
Gifu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee for Medical Research
Address
1-1 Yanagido, Gifu City, Gifu
Tel
058-230-6000
rinri@t.gifu-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
| 2026 | Year | 01 | Month | 01 | 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 | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Extract patient background, circulatory dynamics, and vasopressor usage from medical records/anesthesia logs of patients receiving TUR-bt under spinal anesthesia. Collect blood samples twice preoperatively (before 5-ALA oral administration and upon entering the operating room) and after anesthesia induction to measure vasodilator concentrations. Compare these with patients not receiving oral 5-ALA.
Management information
Registered date
| 2025 | Year | 12 | Month | 26 | Day |
Last modified on
| 2025 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068839
