head and neck cancer head and neck cancer
Conditions
Interventions
Surgery operation (neuroanastomosis)
Sponsors
Uemura Hirokazu
Toyobo Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Primary registration (preoperative) 1. Resectable (no settings for surgical methods) locally advanced head and neck cancer (histologically or cytologically proven squamous cell carcinoma, papillary adenocarcinoma, follicular carcinoma, adenocarcinoma, adenoid cystic carcinoma, mucoepidermoid carcinoma, and so on) and scheduled to undergo reconstruction of single or multiple cranial nerves (hypoglossal nerve, vagus nerve or recurrent laryngeal nerve, accessory nerve, facial nerve). 2. patients with any of the following condition at the TN stage based on imaging and clinical findings (i) Patients with obvious neuro-invasion mentioned above preoperatively and evaluated as cT4 (ii) Patients who may be intraoperatively determined to be T4 (with nerve invasion as described above) (iii) Patients who are judged preoperatively to require concurrent resection of the above-mentioned nerves due to invasion by resectable cervical lymph node metastasis (or due to encirclement of the above-mentioned nerves by cervical lymph node metastasis) (iv) Patients who may be judged intraoperatively to require concurrent resection of the above-mentioned nerves due to invasion by resectable cervical lymph node metastasis (or due to encirclement of the above-mentioned nerves by cervical lymph node metastases) 3. 18 to 80 years of age. 4. ECOG Performance status 0 or 1 (within one month prior to obtaining written informed consent) 5. Patients with written informed consent for this clinical research obtained from the patient themselves or their legal guardians. Secondary registration (intraoperative; before excision of lesion) Any of the following applies based on intraoperative findings: 1. Patient in whom resectableT4 tumor invasion to the above-mentioned nerves is confirmed and the concurrent nerve resection is necessary. 2. Patients in whom invasion to the above-mentioned nerve by resectable cervical lymph node metastasis (or the above-mentioned nerve encirclement by cervical lymph node metastasis) is confirmed and the concurrent nerve resection is necessary.
Exclusion criteria
Exclusion criteria: Primary registration (preoperative) 1. Histologically or cytologically proven anaplastic carcinoma of thyroid. 2. Unresectable locally advanced head and neck cancer. 3. History of hypersensitivity for polyglycolic acid and collagen. 4. Judged to be inappropriate for this study for any other reason by an investigator. Secondary registration (intraoperative; before excision of lesion) 1. When nerve reconstruction using nerve regeneration guide tube (Nerbridge) exceeds 40 mm in length 2. Patients evaluated as not being able to achieve curative surgical treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The functional recovery score of the organ regulated by reconstructed nerve at postoperative after one year. Each person's score is defined as an average score of reconstructions. If multiple reconstructions are performed. Methods to measure the functional recovery score. 1.Vocal cord movement; endoscopy. 2.Facial movement; The facial movement of the relevant site of the face is evaluated by inspection. 3.Upper limb abduction movement; upper limb elevation angle. 4.Tongue movement; visual examination. Functional recovery score Not recovered (0) Mild (1) Moderate (2) Complete (3) Vocal cord movement No movements are observed. (0) Abduction or adduction is observed. (1) Abduction and adduction are observed, but inferior to preoperative movement or to movement on healthy side. (2) Abduction and adduction are observed, and equivalent to preoperative movement or to movement on healthy side. (3) Facial movement No movement of the relevant site of the face.(0) Slight movement of the relevant site of the face.(1) The movement of the relevant site of the face is clearly confirmed, but it does not lead to preoperative movement or healthy side movement.(2) The movement of the relevant site of the face is equivalent to preoperative movement or healthy side movement.(3) Upper limb abduction movement <=90 degrees(0) 90 degrees <, <=120 degrees (1) 120<, <=150 degrees (2) 150 degrees < (3) Tongue movement Affected side deviation of the tip of the tongue. (0) Affected side slight deviation of the tip of the tongue and not moved to the midline. (1) Fixed near the midline. (2) Movable to affected and healthy side. (3) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Motor function recovery score for each part It is evaluated by the methods (1-4) for each part. 2. Interval between surgery and functional recovery It is calculated as a period from the date of surgery to the date of motor function recovery. | — |
Contacts
Public ContactHirokazu Uemura
Nara Medical University Hospital
Outcome results
None listed