Trigeminal Neuralgia, SecondaryNCT03549013
3D-CT-guided Percutaneous Radiofrequency Thermocoagulation for Tumor-related Trigeminal Neuralgia
An observational study of Trigeminal Neuralgia, Secondary, run by Beijing Tiantan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigeminal Neuralgia, Secondary
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2018to 5 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- patients with infection at the puncture site,
- coagulopathy,
- epilepsy,
- other causes of TN,
- a history of mental disorders or anesthetic drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Long-Term Outcome of 3D-CT-guided Percutaneous Radiofrequency Thermocoagulation for Tumor-related Trigeminal Neuralgia: A Retrospective Study.
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.
Read the 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.
- Conditions
- Trigeminal Neuralgia, Secondary
- Keywords
- Tumor-related Trigeminal Neuralgia, Percutaneous Radiofrequency Thermocoagulation, Three-dimensional Computed Tomography
- Medical subject headings
- Trigeminal Neuralgia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (2)
Patient satisfaction
Patient satisfaction is evaluated by a 5-point Likert scale, while 1 point represents very unsatisfactory and 5 points indicates very satisfactory
Measured: From pre-operation to 1 week after operation
Adverse events
Data regarding intra-and post=operative adverse events.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start29 Apr 2018
- Primary completion5 May 2018
- Study completion5 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Trigeminal Neuralgia, SecondaryStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
- Investigators
- Fang Luo, M.D., Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549013
- Sponsor's protocol ID
- KY 2018-024-02
- Status last verified
- Jun 2018
- First submitted
- 21 May 2018
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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. doi: 10.3171/2015.7.JNS15451. Epub 2016 Jan 22.
PubMed 26799302Cho 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 May;56(5):883-889. doi: 10.1111/head.12801. Epub 2016 Apr 4.
PubMed 27041354Furtado 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.
PubMed 20190946Cheng TM, Cascino TL, Onofrio BM. Comprehensive study of diagnosis and treatment of trigeminal neuralgia secondary to tumors. Neurology. 1993 Nov;43(11):2298-302. doi: 10.1212/wnl.43.11.2298.
PubMed 8232946Khan 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.
PubMed 28043883Kobata 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. doi: 10.1097/00006123-200202000-00008.
PubMed 11844262Kanpolat 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. doi: 10.1097/00006123-200103000-00013.
PubMed 11270542Fraioli 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. doi: 10.1227/00006123-198902000-00014.
PubMed 2783993Emril 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.
PubMed 21311718
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-Term Outcome of 3D-CT-guided Percutaneous Radiofrequency Thermocoagulation for Tumor-related Trigeminal Neuralgia: A Retrospective Study.
- ClinicalTrials.gov ID
- NCT03549013
- Acronym / sponsor ID
- KY 2018-024-02
- Conditions
- Trigeminal Neuralgia, Secondary
- Keywords
- Tumor-related Trigeminal Neuralgia, Percutaneous Radiofrequency Thermocoagulation, Three-dimensional Computed Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 29 Apr 2018 (actual)
- Primary completion
- 5 May 2018 (actual)
- Study completion
- 5 May 2018 (actual)
- First posted
- 7 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- patients with infection at the puncture site,
- coagulopathy,
- epilepsy,
- other causes of TN,
- a history of mental disorders or anesthetic drug abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Patient satisfaction
Time frame: From pre-operation to 1 week after operation
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
- Background: PubMed 26799302Kim 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. doi: 10.3171/2015.7.JNS15451. Epub 2016 Jan 22.
- Background: PubMed 27041354Cho 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 May;56(5):883-889. doi: 10.1111/head.12801. Epub 2016 Apr 4.
- Background: PubMed 20190946Furtado 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.
- Background: PubMed 8232946Cheng TM, Cascino TL, Onofrio BM. Comprehensive study of diagnosis and treatment of trigeminal neuralgia secondary to tumors. Neurology. 1993 Nov;43(11):2298-302. doi: 10.1212/wnl.43.11.2298.
- Background: PubMed 28043883Khan 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.
- Background: PubMed 11844262Kobata 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. doi: 10.1097/00006123-200202000-00008.
- Background: PubMed 11270542Kanpolat 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. doi: 10.1097/00006123-200103000-00013.
- Background: PubMed 2783993Fraioli 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. doi: 10.1227/00006123-198902000-00014.
- Background: PubMed 21311718Emril 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fang Luo, M.D. principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trigeminal Neuralgia, Secondary, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03549013, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2018.