Assessment of the efficacy and safety of accessory nerve reconstruction using nerve regeneration inducing tube in neck dissection for patients with head and neck cancer - A Prospective Multicenter Clinical Study

Assessment of the efficacy and safety of accessory nerve reconstruction using nerve regeneration inducing tube in neck dissection for patients with head and neck cancer - A Prospective Multicenter Clinical Study - Assessment of the efficacy and safety of accessory nerve reconstruction using nerve regeneration inducing tube in neck dissection- A Prospective Multicenter Clinical Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032336

Enrollment

Registered

2018-04-20

Start date

2018-04-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and neck cancer

Interventions

accessory nerve reconstruction using nerve regeneration inducing tube in neck dissection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Head and Neck cancer(Lip and Oral Cavity, Nasal sinus, Nasopharynx, Oropharynx, Hypopharynx, Larynx, Salivary gland) proven histologically and scheduled to undergo unilateral neck dissection including Level II,III and IV. 2)Patients who can undergo rehabilitation and access the functions postoperatively. 3)ECOG PS 0-1 within 14 days before the registration 4)Adequate organ function. 5)Patients who can answer the survey questions . 6)Having provided voluntary written consent for participation in this study.

Exclusion criteria

Exclusion criteria: 1)Patients who underwent the ipsilateral neck dissection or radiotherapy before. 2)Patients who registered other clinical trial (intervention study or Japanese registration trial) for head and neck cancer before. 3)Patients with infections requiring systematic treatment 4)Multiple malignancies except for carcinoma in situ and intramucosal cancer. 5)uncontrolable diabetes 6)severe heart disease such as myocardial infarction within six months and unstable angina. 7)uncontrolabel hypertension 8)pulmonary disease with over class 3 in American Society of Anesthesiologists physical status classification 9)Patients with a history of hypersensitivity for polyglycolic acid and collagen. 10)Patients with continuous systemic administration of steroid or immunosuppressant 11)Patients with the possibility of pregnancy or pregnancy 12)Patients who are unable oral administration of mecobalamin 13)Patients with gastrointestinal disorders inhibiting the absorption of mecobalamin 14)Patients with mental illness, alcoholism,drug addiction affecting the compliance with the clinical trial. 15)Patients who are judged by an investigator to be inappropriate for this study for any other reason.

Design outcomes

Primary

Measure	Time frame
the active range of shoulder abductive motion at postoperative after 24 months	—

Countries

Japan

Contacts

Public ContactYasuhiro Arai

Yokohama City University Otorhinolaryngology, Head and Neck Surgery

yasuarai@yokohama-cu.ac.jp045-787-2800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026