UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054939 |
|---|---|
| Receipt number | R000062554 |
| Scientific Title | Assessing the Risk of Intraoperative Hypotension Induced by 5-Aminolevulinic Acid in Malignant Glioma and Lymphoma Patients |
| Date of disclosure of the study information | 2024/07/11 |
| Last modified on | 2024/07/11 16:51:39 |
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Basic information
Public title
The Effect of 5-Aminolevulinic Acid on Intraoperative Hypotension in Brain Tumor Patients
Acronym
The 5-ALA test
Scientific Title
Assessing the Risk of Intraoperative Hypotension Induced by 5-Aminolevulinic Acid in Malignant Glioma and Lymphoma Patients
Scientific Title:Acronym
The 5-ALA test
Region
| Japan |
Condition
Condition
Malignant glioma, Malignant lymphoma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the risk of intraoperative hypotension associated with oral administration of 5-ALA in patients with malignant glioma and malignant lymphoma, and to provide specific insights for improving anesthesia management.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of intraoperative hypotension
Key secondary outcomes
Duration of intraoperative hypotension
Severity of intraoperative hypotension
30-day postoperative mortality
Incidence of postoperative complications
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent intracranial tumor resection for malignant glioma and malignant lymphoma at Jikei University Kashiwa Hospital between January 2015 and May 2024.
Key exclusion criteria
Patients under 18 years of age
Patients undergoing surgery not managed by the Department of Anesthesiology
Patients who declined to participate in the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Kase |
Organization
The Jikei University School of Medicine Kashiwa Hospital
Division name
Department of Anesthesiology
Zip code
277-8567
Address
163-1 Kashiwashita, Kashiwa City, Chiba Prefecture
TEL
04-7164-1111
y.kase@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Kazuma |
| Middle name | |
| Last name | Oshida |
Organization
The Jikei University School of Medicine Kashiwa Hospital
Division name
Department of Anesthesiology
Zip code
04-7164-1111
Address
163-1 Kashiwashita, Kashiwa City, Chiba Prefecture
TEL
04-7164-1111
Homepage URL
yensid.725@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
The Jikei University Clinical Research Review Committee
Address
3-25-8 Nishi-Shimbashi, Minato-ku Tokyo 105-8461 Japan
Tel
03-3433-1111
crb@jikei.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
| 2024 | Year | 07 | Month | 11 | 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
| 2024 | Year | 07 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the association between oral administration of 5-ALA and intraoperative hypotension in patients with malignant glioma and malignant lymphoma, and to provide specific insights for improving anesthetic management.
Management information
Registered date
| 2024 | Year | 07 | Month | 11 | Day |
Last modified on
| 2024 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062554
