RECONNECT Study

Not Applicable

Recruiting

• Conditions: head and neck cance; D006258

• Registration Number: JPRN-jRCTs052210092
• Lead Sponsor: emura Hirokazu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified