| 目的/Objectives |
| 目的1/Narrative objectives1 |
脳脊髄液減少症において各検査で漏出部位が特定された症例を脳脊髄液漏出症と定義されています。本研究では漏出部位特定を行う検査方法についての研究であり、脳脊髄液減少症を研究対象とする。
脳脊髄液減少症に対する治療法としてはブラッドパッチの保険収載が決まるなど、注目を集めている。治療は基本的に「脳脊髄液漏出症画像判定基準・画像診断基準」に沿って行われている。現在の脳脊髄液減少症の問題点は、「脳脊髄液漏出症画像判定基準・画像診断基準」に提示されたCTミエロ、MRIミエロ、RI脳槽シンチにて漏出部位が特定されたものを脳脊髄液漏出症としてブラッドパッチのよい適応とされているが、8割を超える多くの症例が脳脊髄液漏出症画像判定基準・画像診断基準の検査方法では漏出部位が特定されず脳脊髄液漏出症とは診断されないことである。これはブラッドパッチを漏出部位近傍に行うと明示された診断基準に沿っても非常に大きな問題点と言える。
我々が提案する新しい検査方法は漏出部位の検出において従来の造影剤や放射性物質を使用する検査方法に比べ、副作用を大きく減らし、かつ診断精度を大きく上げると思われる。また、コスト面でも大きな改善が見込まれる。そのため、将来においては脳脊髄液減少症の第一選択の検査方法となる可能性があると期待される。当研究ではこの新しい検査方法の安全性の評価を行なう。 |
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.
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| 目的2/Basic objectives2 |
安全性/Safety |
| 目的2 -その他詳細/Basic objectives -Others |
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| 試験の性質1/Trial characteristics_1 |
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| 試験の性質2/Trial characteristics_2 |
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| 試験のフェーズ/Developmental phase |
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| 評価/Assessment |
| 主要アウトカム評価項目/Primary outcomes |
有害事象の有無、種類、重症度、安全度、発現頻度および発現期間を評価する。
有害事象の収集期間：当該検査法の消毒開始時から退院後1週間後の再診時までとする。（許容範囲は－3日＋7日とする） |
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)
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| 副次アウトカム評価項目/Key secondary outcomes |
漏出箇所部位（従来の検査方法と新しい当該検査方法の比較を行う）
同意取得時、退院時、退院後1週間後の再診時、退院後3か月後の再診時のVASスコア（許容範囲は±1ヶ月とする）
退院時以外のVASスコアは評価時より１週間以内の最大の痛みを記載する。 |
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. |
| 介入/Intervention |
| 群数/No. of arms |
1 |
| 介入の目的/Purpose of intervention |
診断/Diagnosis |
| 介入の種類/Type of intervention |
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| 介入1/Interventions/Control_1 |
脳脊髄液漏出症画像判定基準・画像診断基準に従い脳脊髄液減少症と診断し、提示されているCTミエロ、RI脳槽シンチを行ったうえで、新たな脳脊髄手術用洗浄灌流液髄注検査法を行います。それぞれの検査結果を踏まえて硬膜破損部位を特定する。確認された漏出部位に対してはブラッドパッチを施行する。異なる部位が示された場合には最も漏出が疑われる部位を優先的に処置する。
新たな検査方法はCTミエロ、RI脳槽シンチと同じ方法で腰椎穿刺を行い脳脊髄手術用洗浄灌流液を20ｍL髄注します。これにより容量を超えた脳脊髄液が硬膜外にあふれ、これを髄注後にMRIで撮影する。
この手技の安全性について当研究対象の検査直後、退院時、退院後1週間後の最新時に評価を行い、副次的に漏出部位検出の精度を評価する。
新検査法で脳脊髄液減少症の漏出部位を特定するものであり、従来の検査方法で漏出部位を特定でき脳脊髄液漏出症と診断された症例のみならず、すべての脳脊髄液減少症を対象とします。 |
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.
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| 介入2/Interventions/Control_2 |
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| 介入3/Interventions/Control_3 |
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| 介入4/Interventions/Control_4 |
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| 介入5/Interventions/Control_5 |
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| 介入6/Interventions/Control_6 |
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| 介入7/Interventions/Control_7 |
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| 介入8/Interventions/Control_8 |
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| 介入9/Interventions/Control_9 |
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| 介入10/Interventions/Control_10 |
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| 適格性/Eligibility |
| 年齢（下限）/Age-lower limit |
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| 年齢（上限）/Age-upper limit |
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| 性別/Gender |
男女両方/Male and Female |
| 選択基準/Key inclusion criteria |
髄液圧が60mmH2O以下の18歳以上の患者 |
Patients 18 years or older for whom cerebrospinal fluid pressure was 60mmH2O or less. |
| 除外基準/Key exclusion criteria |
意思疎通が困難な患者、出血傾向がある患者、造影剤・RIに対しアレルギーを有する患者、腰椎穿刺が困難な患者、妊婦、医師により不適格と判定された患者 |
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. |
| 目標参加者数/Target sample size |
5 |
| 結果/Result |
| 結果掲載URL/URL related to results and publications |
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| 組み入れ参加者数/Number of participants that the trial has enrolled |
5 |
| 主な結果/Results |
5症例中、4症例で有害事象は認めず。1症例だけ注入後に一時的に軽度の頭痛を認めた。Overflow leak testでは全症例で漏出個所を特定できた。CTミエロでは5症例中、3症例で漏出個所を特定できた。この3症例の漏出個所はOverflow leak testの漏出個所と一致した |
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. |
| 主な結果入力日/Results date posted |
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| 結果掲載遅延/Results Delayed |
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| 結果遅延理由/Results Delay Reason |
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| 最初の試験結果の出版日/Date of the first journal publication of results |
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| 参加者背景/Baseline Characteristics |
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| 参加者の流れ/Participant flow |
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| 有害事象/Adverse events |
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| 評価項目/Outcome measures |
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| 個別症例データ共有計画/Plan to share IPD |
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| 個別症例データ共有計画の詳細/IPD sharing Plan description |
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