UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022549 |
|---|---|
| Receipt number | R000025756 |
| Scientific Title | Safety evaluation of intraspinal injection of cleaning perfusate for cerebrospinal surgery on the diagnosis of cerebrospinal fluid(CSF)-leakage in CSF hypovolemia |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2019/12/03 15:09:15 |
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Basic information
Public title
Safety evaluation of intraspinal injection of cleaning perfusate for cerebrospinal surgery on the diagnosis of cerebrospinal fluid(CSF)-leakage in CSF hypovolemia
Acronym
SICCS study
Scientific Title
Safety evaluation of intraspinal injection of cleaning perfusate for cerebrospinal surgery on the diagnosis of cerebrospinal fluid(CSF)-leakage in CSF hypovolemia
Scientific Title:Acronym
SICCS study
Region
| Japan |
Condition
Condition
cerebrospinal fluid hypovolemia
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In cases of cerebrospinal fluid hypovolemia, those for which a leakage site has been identified at each examination are defined as spontaneous cerebrospinal fluid leak syndrome. The present research is a study on examination methods used to specify leakage sites with cases of cerebrospinal fluid hypovolemia as the research subjects.
Blood patches are used as a treatment method for cases of cerebrospinal fluid hypovolemia. The current problem area in cases of cerebrospinal fluid hypovolemia is that, in many cases, CT myelography, MRI myelography, and RI cisternography cannot identify the site of leakage. This can be said to be an extremely large problem in conducting a blood patch in the vicinity of the leakage site.
Regarding detection of leakage sites, we believe the new examination method we propose will-compared to conventional examination methods using contrast agents or radioactive materials-largely reduce side effects, in addition to greatly increasing diagnostic accuracy. It is expected to be a large improvement in terms of cost as well. Consequently, it is expected that there is the potential for this examination method to become the first choice in cerebrospinal fluid hypovolemia examination in the future. In the present study, an evaluation of the safety of this new examination method was conducted.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The presence or absence of adverse events, the type, the severity, the safety integrity, incidence frequency, and incidence duration were assessed.
Duration for which information on the presence or absence of adverse events was collected: From the start of disinfection for the examination to the follow-up one week after discharge from the hospital. (The permissible range was - 3 days + 7 days)
Key secondary outcomes
Leakage point (a comparison of the conventional examination method and the new examination method from this study was conducted)
VAS score at the time consent was obtained, at the time of discharge from the hospital, at the follow-up one week after discharge from the hospital, and at the follow-up three months after discharge from the hospital (The permissible range was -+ 1 month)
VAS score was obtained the maximum of pain in less than one week from the evaluation.VAS score at discharge are excluded.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Cases were diagnosed with cerebrospinal fluid hypovolemia in accordance with cerebrospinal fluid leakage syndrome image judgment criteria and image diagnostic criteria. After conducting the presented CT myelography and RI cisternography, the new cleansing perfusate intraspinal injection method for cerebrospinal surgery use was conducted. Based on the respective examination results, the dura mater damage site was specified. Blood patches were implemented at the confirmed leakage sites. When differing sites were indicated, the site in which leakage was most suspected was preferentially treated.
The new examination method-which conducts a lumbar puncture using the same method as CT myelography and RI cisternography-intraspinally injected 20mL of the cleansing perfusate for cerebrospinal surgery use. Through this, the cerebrospinal fluid which exceeded capacity overflowed into the epidural space and was shown through MRI after the intraspinal injection.
To evaluate the safety of this technique, assessments were conducted with subjects of this study directly after the examination, at the time of discharge, and latest one week after discharge from the hospital, and the accuracy of the leakage site detection was secondarily evaluated.
With the new evaluation method, we intend to identify leakage sites in cerebrospinal fluid hypovolemia, not only for cases in which the leakage sites can be identified and a diagnosis of spontaneous cerebrospinal fluid leakage symptom given by conventional examination methods, but for all cases of cerebrospinal fluid hypovolemia.
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 18 years or older for whom cerebrospinal fluid pressure was 60mmH2O or less.
Key exclusion criteria
Patients with difficulty communicating, patients with a bleeding tendency, patients allergic to contrast agents or RI, patients for whom lumbar puncture is difficult, pregnant women,patients who have been determined ineligible by the evaluator.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Nakai |
Organization
Kochi Medical School, Kochi University
Division name
Department of Neurosurgery
Zip code
783-8505
Address
Kohasu 185-1, Okocho, Nankoku, Kochi, Japan
TEL
+810888802397
enakai@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Eiichi |
| Middle name | |
| Last name | Nakai |
Organization
Kochi Medical School, Kochi University
Division name
Department of Neurosurgery
Zip code
783-8505
Address
Kohasu 185-1, Okocho, Nankoku, Kochi, Japan
TEL
+810888802397
Homepage URL
enakai@kochi-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Kochi Medical School, Kochi University
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery, Kochi Medical School, Kochi University
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
Kochi Medical School Hospital Certified Ethics Review Board
Address
Kohasu 185-1, Okocho, Nankoku, Kochi, Japan
Tel
+810888802397
enakai@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
| 2016 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
5
Results
No adverse event was observed in 4 out of 5 cases. A mild headache was observed temporarily after injection in only one case. Overflow leak test was able to identify the leakage site in all cases. The CT myelography was able to identify the leakage site in 3 out of 5 cases. The leakage points in these three cases coincided with those in the Overflow leak test.
Results date posted
| 2019 | Year | 06 | Month | 04 | Day |
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
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 31 | Day |
Last modified on
| 2019 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025756
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