UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037211 |
|---|---|
| Receipt number | R000042427 |
| Scientific Title | A Comprehensive Analysis on the Outcomes of Gamma Knife Radiosurgery for Dural Arteriovenous Fistulas: Retrospective Nation-wide Multi-institutional Study |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2022/06/21 20:02:45 |
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Basic information
Public title
A Comprehensive Analysis on the Outcomes of Gamma Knife Radiosurgery for Dural Arteriovenous Fistulas: Retrospective Nation-wide Multi-institutional Study
Acronym
JLGK1802
Scientific Title
A Comprehensive Analysis on the Outcomes of Gamma Knife Radiosurgery for Dural Arteriovenous Fistulas: Retrospective Nation-wide Multi-institutional Study
Scientific Title:Acronym
JLGK1802
Region
| Japan |
Condition
Condition
Dural Arteriovenous Fistulas
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The goal of this study is to demonstrate the efficacy of gamma knife (GK) for dural arteriovenous fistula (DAVF), especially as an initial and sole treatment modality. Many neurosurgeons consider endovascular embolization and direct surgery are the current standard therapeutic modalities for DAVFs, and GK has generally been considered as an alternative when the first two methods are not feasible or fail. However, the accumulation of retrospective evidence from single institutions have suggested that GK could outweigh the other modalities in light of the efficacies and minimal invasiveness. Some might argue that GK is not favorable for hemorrhagic or symptomatic DAVFs because the effect of GK might develop over years; however, many GK surgeons have actually experienced few cases of post-radiosurgical hemorrhage. Rapid improvement of associated symptoms within a couple of months is also possible. To establish evidence that GK is suitable as an initial and sole treatment modality with appropriate external validity, it is desirable to conduct a further study which will (i) clarify factors associated with fistula obliteration and assess the reasons for failed obliteration in order to provide better radiosurgical planning, and (ii) uncover the detailed outcomes by fistula locations, as the outcomes of surgical/endovascular treatments highly depend on the location, and (iii) evaluate the outcomes for those with a prior hemorrhage and/or high-risk features, with or without prior interventions. To accomplish them, the study should be based on a large number of study participants, which can only be achieved by conducting a nation-wide multi-institutional study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Fistula obliteration, disease-specific mortality
Key secondary outcomes
Treatment-related complication, neurological function
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
Patients with dural arteriovenous fistulas treated with gamma knife between January 1, 1997 and December 31, 2016.
If a patient has 2 or more fistulas;
- If 2 or more lesions were treated with gamma knife, they should be registered as independent lesions only if they were located at an adequate distance from each other (farther than each other's 20% isodose line).
- If one of them was treated with gamma knife, the one should be registered; however, presence of the other lesions should also be clarified.
- Data on patients with 2 or more fistulas should be only used for the analyses for obliteration, because the analyses on hemorrhage and complications would become inappropriate as those rates of patients with 2 or more fistulas might be different by nature from patients with only one fistula.
Key exclusion criteria
1. Patient with a history of radiation therapy to the brain.
2. Patient without any follow-up image study.
3. Patient under 20 years.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Shin |
Organization
The University of Tokyo
Division name
Department of Neurosurgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5800-8853
SHIN-NSU@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Kawashima |
Organization
The University of Tokyo
Division name
Department of Neurosurgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5800-8853
Homepage URL
mrkawashima-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Elekta research grant
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo, Clinical Research Review Board
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 JAPAN
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2019 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35677982/
Number of participants that the trial has enrolled
253
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 05 | Month | 31 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 15 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 15 | Day |
Other
Other related information
The manuscript on this study was accepted in Journal of Stroke on 3/16/2022.
The manuscript was published on 5/31/2022.
Management information
Registered date
| 2019 | Year | 06 | Month | 30 | Day |
Last modified on
| 2022 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042427
