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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022549
Receipt No. 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

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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
Email 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
Email enakai@kochi-u.ac.jp

Sponsor
Institute Department of Neurosurgery, Kochi Medical School, Kochi University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025756

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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