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

Trigeminal Neuralgia, Secondary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03549013
• Other study ID #: KY 2018-024-02
• Status: Completed
• Start date: April 29, 2018
• Est. completion date: May 5, 2018

Study information

• Verified date: June 2018
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 5, 2018
• Est. primary completion date: May 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia
• Trigeminal Neuralgia, Secondary

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

References & Publications (9)

Cheng TM, Cascino TL, Onofrio BM. Comprehensive study of diagnosis and treatment of trigeminal neuralgia secondary to tumors. Neurology. 1993 Nov;43(11):2298-302. — View Citation

Cho KR, Lee MH, Im YS, Kong DS, Seol HJ, Nam DH, Lee JI. Gamma knife radiosurgery for trigeminal neuralgia secondary to benign lesions. Headache. 2016 Apr 4. doi: 10.1111/head.12801. [Epub ahead of print] — View Citation

Emril DR, Ho KY. Treatment of trigeminal neuralgia: role of radiofrequency ablation. J Pain Res. 2010 Dec 12;3:249-54. doi: 10.2147/JPR.S14455. — View Citation

Fraioli B, Esposito V, Guidetti B, Cruccu G, Manfredi M. Treatment of trigeminal neuralgia by thermocoagulation, glycerolization, and percutaneous compression of the gasserian ganglion and/or retrogasserian rootlets: long-term results and therapeutic protocol. Neurosurgery. 1989 Feb;24(2):239-45. — View Citation

Furtado SV, Hegde AS. Trigeminal Neuralgia Due to a Small Meckel's Cave Epidermoid Tumor: Surgery Using an Extradural Corridor. Skull Base. 2009 Sep;19(5):353-7. doi: 10.1055/s-0029-1220201. — View Citation

Kanpolat Y, Savas A, Bekar A, Berk C. Percutaneous controlled radiofrequency trigeminal rhizotomy for the treatment of idiopathic trigeminal neuralgia: 25-year experience with 1,600 patients. Neurosurgery. 2001 Mar;48(3):524-32; discussion 532-4. — View Citation

Khan N, Michael A, Choucair A, Bit-Ivan E. Trigeminal Ganglioneuroma: A Rare Case of Trigeminal Neuralgia Caused by Cerebellopontine Angle Tumor. World Neurosurg. 2017 Mar;99:811.e7-811.e10. doi: 10.1016/j.wneu.2016.12.085. Epub 2016 Dec 30. — View Citation

Kim SK, Kim DG, Se YB, Kim JW, Kim YH, Chung HT, Paek SH. Gamma Knife surgery for tumor-related trigeminal neuralgia: targeting both the tumor and the trigeminal root exit zone in a single session. J Neurosurg. 2016 Oct;125(4):838-844. Epub 2016 Jan 22. — View Citation

Kobata H, Kondo A, Iwasaki K. Cerebellopontine angle epidermoids presenting with cranial nerve hyperactive dysfunction: pathogenesis and long-term surgical results in 30 patients. Neurosurgery. 2002 Feb;50(2):276-85; discussion 285-6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative recurrence-free rate	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.	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.
Secondary	Patient satisfaction	Patient satisfaction is evaluated by a 5-point Likert scale, while 1 point represents very unsatisfactory and 5 points indicates very satisfactory	From pre-operation to 1 week after operation
Secondary	Adverse events	Data regarding intra-and post=operative 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.