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临床试验/NCT03549013
NCT03549013已完成不适用

The Long-Term Outcome of 3D-CT-guided Percutaneous Radiofrequency Thermocoagulation for Tumor-related Trigeminal Neuralgia: A Retrospective Study.

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2018年4月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
1
主要终点
Cumulative recurrence-free rate

研究概览

简要总结

This study is designed to investigate the effectiveness and safety of 3D-CT-guided percutaneous radiofrequency thermocoagulation for the treatment of tumor-related trigeminal neuralgia.

详细描述

Approximately 1-13% of trigeminal neuralgia cases are secondary to intracranial tumors, and this condition is referred to as tumor-related trigeminal neuralgia (TRTN). TRTN can result from a lesion affecting any location along the pathway of the trigeminal nerve, such as Meckel's Cave, the posterior fossa, and the cerebellopontine angle. The posterior fossa is the most common location of TRTN, whereas meningioma and epidermoid cysts are the most common pathologies. The goals of TRTN treatment include controlling tumors and relieving pain. Tumor resection is regarded as the most effective treatment, and complete tumor removal is often followed by complete pain remission. However, for patients who cannot undergo the risk of a craniotomy and those with end-stage of malignant tumors or slow-growing benign tumors, surgery may not be the best choice. Conservatively, medication is considered the first-line therapy for relieving pain. However, pharmacology cannot provide satisfactory relief for all patients, and some patients may experience intolerable side effects. For these patients, minimally invasive interventional techniques are preferred. Radiosurgery has been commonly performed for the treatment of TRTN with promising efficacy. However, this intervention is associated with delayed latency of response. Percutaneous radiofrequency thermocoagulation (PRFT) is a low-risk, minimally invasive technique with an acute success rate of 97.6-99%. PRFT remains the most common percutaneous treatment for TN. In addition, this popular procedure may also safely and effectively be repeated if pain recurs. The PRFT procedure involves positioning the radiofrequency (RF) needle at the Gasserian ganglion via the foremen ovale. Suboptimal piercing may lead to unpleasant complications, including cerebrospinal fluid leakage, cranial nerve (VI) palsy and intracranial hemorrhage. Recently, computed tomography (CT) has been demonstrated to be a useful method to identify the optimal position and predict the intraoperative difficulties of the intervention.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age>18 years,
  • typical TN symptoms in the same lateral as intracranial tumors,
  • uncontrolled symptoms or intolerable side effects of medication,
  • pain duration longer than 90 days
  • brain magnetic resonance imaging (MRI)confirmed that the trigeminal pain was secondary to intracranial tumors.

排除标准

  • patients with infection at the puncture site,
  • coagulopathy,
  • epilepsy,
  • other causes of TN,
  • a history of mental disorders or anesthetic drug abuse.

结局指标

主要结局

Cumulative recurrence-free rate

时间窗: The enrollment of our study began on March 1st 2007 and ended on 31st October 2017. All following-up has been finished before February 28th 2018.

The modified Barrow Neurological Institute (BNI) pain intensity score will be used to assess pain degree. Pain relief degree will be evaluated as BNI I= no pain without medication, BNI II= occasional pain, not require medication, BNI IIIa= no pain with medication, BNI IIIb= Controlled pain with medication, BNI IV= improved pain that inadequately controlled by medication, BNI IV= persistent pain that inadequately controlled by medication. A BNI grade that increased to IV-V from I-IIIb after operation was defined as recurrence.

次要结局

  • Patient satisfaction(From pre-operation to 1 week after operation)
  • Adverse events(The enrollment of our study began on March 1st 2007 and ended on 31st October 2017. All following-up has been finished before February 28th 2018.)

研究者

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fang Luo

vice director of Department of Anesthesiology and Pain Management

Beijing Tiantan Hospital

研究点 (1)

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