RECONNECT Study

JRCT ID: jRCTs052210092

Registered date:28/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: head and neck cancer
• Date of first enrollment: 20/12/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Surgery operation (neuroanastomosis)

Outcome(s)

Primary Outcome

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 Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Uemura Hirokazu
• Secondary Sponsor: Toyobo Co., Ltd.