Radiographic Prediction of the Nerve Origin of Neck Peripheral Nerve Sheath Tumors

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	20 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- Previous anterior neck surgery.

- Malignant disease.

- Prior neck radiation.

- Undetermined intraoperative nerve origin.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05684835
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	National Cheng-Kung University Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Taiwan
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Peripheral Nerve Sheath Tumors, Schwannoma of Neck

Additional Details

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.

Arms & Interventions

Arms

: Vagus nerve tumor group

patients with neck peripheral nerve sheath tumors originating from the vagus nerve

: Sympathetic nerve tumor group

patients with neck peripheral nerve sheath tumors originating from the sympathetic nerve

: Cervical spinal nerve tumor group

patients with neck peripheral nerve sheath tumors originating from the cervical spinal nerve

Interventions

Procedure: - Excision

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.

Contact a Trial Team

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International Sites

National Cheng-Kung University Hospital, Taipei, Taiwan

Status

Recruiting

Address

National Cheng-Kung University Hospital

Taipei, , 704

Site Contact

Chi-Chen Huang, MD

[email protected]

06-2353535 #258821

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