Peripheral Nerve Sheath TumorsNCT05684835
Radiographic Prediction of the Nerve Origin of Neck Peripheral Nerve Sheath Tumors
An observational study of Peripheral Nerve Sheath Tumors and Schwannoma of Neck, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Postoperative nerve palsy is a major complication following resection of neck peripheral nerve sheath tumors. This study is a retrospective cohort aimed to predict the nerve origin of neck peripheral nerve sheath tumors. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Peripheral Nerve Sheath Tumors, Schwannoma of Neck
- What is being tested?
- Excision
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2008to 1 Jun 2023
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an intraoperatively confirmed neck PNST and NO between January 2008 and December 2022 who underwent surgical excision of neck PNST with anterior approach, excluding patients with previous anterior neck surgery, malignant disease, prior neck radiation, and undetermined intraoperative NO.
Who may be able to join
- Patients with clinical diagnosis of neck peripheral nerve sheath tumors.
- Patients received surgery January 2008 and December 2022.
- The nerve origin of peripheral nerve sheath tumor must be intraoperatively confirmed.
Who cannot join
- Previous anterior neck surgery.
- Malignant disease.
- Prior neck radiation.
- Undetermined intraoperative nerve origin.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng-Kung University Hospital
Taipei, 704
Chi-Chen Huang, MD, 06-2353535 ext. 258821, charles042085@hotmail.com
About this study
Official title: Radiographic Prediction of the Nerve Origin of Neck Peripheral Nerve Sheath Tumors: Retrospective Cohort Study
Postoperative nerve palsy is a major complication following resection of neck peripheral nerve sheath tumors. This study is a retrospective cohort aimed to predict the nerve origin of neck peripheral nerve sheath tumors. Accurate preoperative identification of the nerve origin can improve surgical outcomes and patient counseling
Read the detailed description
Postoperative nerve palsy is a major complication following resection of neck peripheral nerve sheath tumors (PNSTs). Accurate preoperative identification of the nerve origin (NO) can improve surgical outcomes and patient counseling. This study aims to predict the NO of neck PNSTs with radiographic analysis. This study is a retrospective cohort analysis. Radiographic parameters will be reviewed and the sensitivity, specificity, accuracy of NO prediction will be evaluated.
- Conditions
- Peripheral Nerve Sheath Tumors, Schwannoma of Neck
- Being tested
- Excision
- Medical subject headings
- Nerve Sheath Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExcisionProcedure or surgery
All patients underwent surgery under general anesthesia and intraoperative neuromonitoring according to the preoperatively predicted NO. Using an anterior cervical approach, the tumor was delineated after identifying the relationships among the great vessels, nerves, and tumors. The NO was confirmed intraoperatively. Sharp dissection was performed meticulously to enucleate the tumor from the NO to preserve most nerve fibers.
| Study group | Role | What they receive |
|---|---|---|
| Vagus nerve tumor group | patients with neck peripheral nerve sheath tumors originating from the vagus nerve Receives: Procedure: Excision | |
| Sympathetic nerve tumor group | patients with neck peripheral nerve sheath tumors originating from the sympathetic nerve Receives: Procedure: Excision | |
| Cervical spinal nerve tumor group | patients with neck peripheral nerve sheath tumors originating from the cervical spinal nerve Receives: Procedure: Excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve origin
intraoperative identification of the nerve origin of the tumor
Measured: within 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start1 Jan 2008
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Nerve Sheath TumorsStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi Chen Huang, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684835
- Sponsor's protocol ID
- A-ER-109-209
- Status last verified
- Jan 2023
- First submitted
- 5 Jan 2023
- Last updated
- 17 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wong CE, Huang CC, Chuang MT, Lee PH, Chen LY, Hsu HH, Huang CY, Wang LC, Lee JS. Quantification of vessel separation using the carotid-jugular angle to predict the nerve origin of neck peripheral nerve sheath tumours: a pooled analysis of cases from the literature and a single-center cohort. Int J Surg. 2023 Sep 1;109(9):2704-2713. doi: 10.1097/JS9.0000000000000491.
PubMed 37204443
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Prediction of the Nerve Origin of Neck Peripheral Nerve Sheath Tumors: Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05684835
- Acronym / sponsor ID
- A-ER-109-209
- Conditions
- Peripheral Nerve Sheath Tumors, Schwannoma of Neck
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 13 Jan 2023 (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.
Postoperative nerve palsy is a major complication following resection of neck peripheral nerve sheath tumors. This study is a retrospective cohort aimed to predict the nerve origin of neck peripheral nerve sheath tumors. Accurate preoperative identification of the nerve origin can improve surgical outcomes and patient counseling
Detailed description
Postoperative nerve palsy is a major complication following resection of neck peripheral nerve sheath tumors (PNSTs). Accurate preoperative identification of the nerve origin (NO) can improve surgical outcomes and patient counseling. This study aims to predict the NO of neck PNSTs with radiographic analysis. This study is a retrospective cohort analysis. Radiographic parameters will be reviewed and the sensitivity, specificity, accuracy of NO prediction will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vagus nerve tumor group | – | Procedure: Excisionpatients with neck peripheral nerve sheath tumors originating from the vagus nerve |
| Sympathetic nerve tumor group | – | Procedure: Excisionpatients with neck peripheral nerve sheath tumors originating from the sympathetic nerve |
| Cervical spinal nerve tumor group | – | Procedure: Excisionpatients with neck peripheral nerve sheath tumors originating from the cervical spinal nerve |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an intraoperatively confirmed neck PNST and NO between January 2008 and December 2022 who underwent surgical excision of neck PNST with anterior approach, excluding patients with previous anterior neck surgery, malignant disease, prior neck radiation, and undetermined intraoperative NO.
Key inclusion criteria (3 listed)
- Patients with clinical diagnosis of neck peripheral nerve sheath tumors.
- Patients received surgery January 2008 and December 2022.
- The nerve origin of peripheral nerve sheath tumor must be intraoperatively confirmed.
Key exclusion criteria (4 listed)
- Previous anterior neck surgery.
- Malignant disease.
- Prior neck radiation.
- Undetermined intraoperative nerve origin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExcisionAll patients underwent surgery under general anesthesia and intraoperative neuromonitoring according to the preoperatively predicted NO. Using an anterior cervical approach, the tumor was delineated after identifying the relationships among the great vessels, nerves, and tumors. The NO was confirmed intraoperatively. Sharp dissection was performed meticulously to enucleate the tumor from the NO to preserve most nerve fibers. | Procedure or surgery | Cervical spinal nerve tumor group, Sympathetic nerve tumor group, Vagus nerve tumor group |
Primary outcome
Nerve origin
Time frame: within 1 month
intraoperative identification of the nerve origin of the tumor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Derived from this study: PubMed 37204443Wong CE, Huang CC, Chuang MT, Lee PH, Chen LY, Hsu HH, Huang CY, Wang LC, Lee JS. Quantification of vessel separation using the carotid-jugular angle to predict the nerve origin of neck peripheral nerve sheath tumours: a pooled analysis of cases from the literature and a single-center cohort. Int J Surg. 2023 Sep 1;109(9):2704-2713. doi: 10.1097/JS9.0000000000000491.
- Individual participant dataSharing planned: No
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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.
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 Peripheral Nerve Sheath Tumors and Schwannoma of Neck, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Jan 2023. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chi-Chen Huang, MD (06-2353535 ext. 258821, charles042085@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nerve origin (time frame: within 1 month). 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 NCT05684835, which also lists 1 linked publication.
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 17 Jan 2023.