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Evaluation of effectiveness of intraspinal injection of cleaning perfusate for cerebrospinal surgery on the diagnosis of cerebrospinal fluid(CSF)-leakage in intracranial hypotension (EICI study)

Evaluation of Overflow leak test (Evaluation of Overflow leak test)

18

Eligibility criteria for participation are: (1) patients with hypocerebrospinal fluid pressure (patients with confirmed cerebrospinal fluid pressure of 60 mm H2O or less), (2) patients over 18 years of age, and (3) patients who are willing to participate in this study (or a substitute if the patient is a minor or lacks the capacity to consent). Subjects must have obtained written consent from their legal partner. Exclusion criteria were: (1) patients with bleeding tendencies, (2) patients for whom lumbar puncture was difficult, (3) pregnant women, and (4) patients deemed ineligible by a physician. The target number of patients was 18, and only patients who met all of the criteria participated. Eighteen patients aged 21 to 84 participated, 10 men and 8 women.

All patients provided written informed consent and the study was conducted as planned. There were no discontinued or dropped cases.

Adverse events included short-term, transient discomfort in two initial cases, but the symptoms improved. No serious adverse events were observed in this study.

CT myelography revealed extradural contrast medium in 4 out of 18 cases, confirming leakage, but in 2 of these cases, the contrast medium was accumulated extensively in the back, and it was judged that the leakage site could not be identified. It was done. As a result, the leak site was identified in 2 out of 18 cases, for an identification rate of 11.1%. On the other hand, in the overflow leak test, the leak site could be identified in 16 out of 18 cases. The identification rate was 88.9%. As for adverse events, temporary discomfort was observed in two initial cases following intrathecal injection of ARTCEREB for the overflow leak test, but this has resolved.

The overflow leak test appears to be clearly more effective than CT myelography as an examination method for diagnosing leak sites in cerebrospinal fluid hypovolemia.

Oct. 31, 2023

No

N/A

https://jrct.mhlw.go.jp/latest-detail/jRCTs061190002

Nakai Eiichi

Kochi Medical School Hospital

Kohasu 185-1, Okocho, Nankoku, Kochi, Japan

enakai@kochi-u.ac.jp

Nakai Eiichi

Kochi Medical School Hospital

Kohasu 185-1, Okocho, Nankoku, Kochi, Japan

+81-88-880-2397

enakai@kochi-u.ac.jp

Complete

May. 01, 2019

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

diagnostic purpose

1. Patient with intracranial hypotension(Patient confirmed to have cerebrospinal fluid pressure below 60mmH2O)
2. Patient 18 years old or above
3. Written consent concerning participation in this research has been obtained from the participant (or from the individual legal guardian if incapable of consenting)

1. Patient with a bleeding tendency
2. Patient for whom a lumbar puncture would be difficult
3. Pregnant woman
4. Patient deemed unfit by a doctor

Both

intracranial hypotension

20 mL of ARTCEREB Irrigation and Perfusion Solution for Cerebrospinal Surgery will be injected into the subarachnoid space using regular lumbar puncture procedure as an overflow leak test. Injection is done at the ward. MRI imaging is done within one hour after injection. Cerebrospinal fluid which subsequently exceeds the volume of the medullary cavity and overflows will be imaged with MRI fat suppression T2WI and compared with the MRI image taken in advance to identify the leakage site.

intracranial hypotension

Artcereb injection

Evaluation of the effectiveness of identifying leakage sites with the overflow leak test through comparison of the overflow leak test and CT myelogram

(1) Comparison of MRI image findings taken as routine care before Overflow leak test and MRI image findings at Overflow leak test.
(2) Name of adverse event, date of onset, severity (severity), severity, treatment for study subject, outcome and date of outcome, causal relationship with the concerned study.

+81-88-880-2180

May. 14, 2019

none