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3D-CT-guided Percutaneous Radiofrequency Thermocoagulation for Tumor-related Trigeminal Neuralgia

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ClinicalTrials.gov Identifier: NCT03549013
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Fang Luo, Beijing Tiantan Hospital

Brief Summary:
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.

Condition or disease
Trigeminal Neuralgia, Secondary

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 38 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Long-Term Outcome of 3D-CT-guided Percutaneous Radiofrequency Thermocoagulation for Tumor-related Trigeminal Neuralgia: A Retrospective Study.
Actual Study Start Date : April 29, 2018
Actual Primary Completion Date : May 5, 2018
Actual Study Completion Date : May 5, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Cumulative recurrence-free rate [ Time Frame: 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.


Secondary Outcome Measures :
  1. Patient satisfaction [ Time Frame: From pre-operation to 1 week after operation ]
    Patient satisfaction is evaluated by a 5-point Likert scale, while 1 point represents very unsatisfactory and 5 points indicates very satisfactory

  2. Adverse events [ Time Frame: 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. ]
    Data regarding intra-and post=operative adverse events.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This retrospective study was conducted in Beijing Tiantan Hospital between March 2007 and February 2018. The local ethics committee approved this study and exempted the informed consent before the collection of patient data. We enrolled a total of 38 patients who fulfilled all following criteria: age>18 years; typical TN symptoms in the same lateral as intracranial tumors; uncontrolled symptoms or intolerable side effects of medication; and pain duration longer than 90 days. To confirm that the trigeminal pain was secondary to tumors, brain magnetic resonance imaging (MRI) was performed in advance. Patients with infection at the puncture site, coagulopathy, epilepsy, other causes of TN, a history of mental disorders or anesthetic drug abuse were excluded from this study.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549013


Locations
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China, Beijing
Beijing Tiantan Hospital
Beijing, Beijing, China, 100050
Sponsors and Collaborators
Beijing Tiantan Hospital
Investigators
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Principal Investigator: Fang Luo, M.D. Beijing Tiantan Hospital

Publications:

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Responsible Party: Fang Luo, vice director of Department of Anesthesiology and Pain Management, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT03549013     History of Changes
Other Study ID Numbers: KY 2018-024-02
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fang Luo, Beijing Tiantan Hospital:
Tumor-related Trigeminal Neuralgia
Percutaneous Radiofrequency Thermocoagulation
Three‐dimensional Computed Tomography
Additional relevant MeSH terms:
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Trigeminal Neuralgia
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Trigeminal Nerve Diseases
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases