Reconstruction of the cranial nerve with a polyglycolic acid-collagen tube (Nerbridge TM) in advanced head and neck cancer patients

emura Hirokazu0 sites10 target enrollmentSeptember 28, 2021

Overview

No summary available.

Registry

who.int

Start Date

September 28, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

emura Hirokazu

•1\.Resectable (no settings are set for surgical procedures) locally advanced head and neck cancer (histologically or cytological proven squamous cell carcinoma, papillary adenocarcinoma, follicular carcinoma, adenocarcinoma, adenoid cystic carcinoma, mucoepidermoid carcinoma) and scheduled to undergo reconstruction of single or multiple cranial nerves (hypoglossal nerve, vagus nerve or recurrent laryngeal nerve, accessory nerve, facial nerve).
•2\.Preoperatively diagnosed cT4, potential T4 which will be diagnosed during surgery, preoperatively diagnosed to be required cranial nerve reconstruction due to resectable cervical lymph node metastasis, likely to be required cranial nerve reconstruction due to resectable cervical lymph node metastasis during surgery.
•3\.Aged 18 to 80 years old.
•4\.ECOG Performance status 0 or 1\.(within one month prior to obtaining consent)
•5\. Written informed consent

•1\.Nerve reconstruction on large defect lengths extending 4\.0 cm or more.
•2\.Histologically or cytological proven undifferentiated carcinoma of thyroid.
•3\.Unresectable locally advanced head and neck cancer.
•4\. History of hypersensitivity for polyglycolic acid and collagen.
•5\. Judged by an investigator to be inappropriate for this study for any other reason.