NCT05684835

Brief 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. Accurate preoperative identification of the nerve origin can improve surgical outcomes and patient counseling

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
15 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

15.4 years

First QC Date

January 5, 2023

Last Update Submit

January 12, 2023

Conditions

Peripheral Nerve Sheath TumorsSchwannoma of Neck

Outcome Measures

Primary Outcomes (1)

  • Nerve origin

    intraoperative identification of the nerve origin of the tumor

    within 1 month

Study Arms (3)

Vagus nerve tumor group

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

Procedure: Excision

Sympathetic nerve tumor group

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

Procedure: Excision

Cervical spinal nerve tumor group

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

Procedure: Excision

Interventions

ExcisionPROCEDURE

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.

Cervical spinal nerve tumor groupSympathetic nerve tumor groupVagus nerve tumor group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Previous anterior neck surgery.
  • Malignant disease.
  • Prior neck radiation.
  • Undetermined intraoperative nerve origin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng-Kung University Hospital

Taipei, 704, Taiwan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37204443DERIVED

MeSH Terms

Conditions

Nerve Sheath Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsPeripheral Nervous System NeoplasmsNervous System NeoplasmsNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular Diseases

Central Study Contacts

Chi-Chen Huang, MD

CONTACT

06-2353535charles042085@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending doctor

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 13, 2023

Study Start

January 1, 2008

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

January 17, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)