UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032336 |
|---|---|
| Receipt number | R000035782 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2018/04/20 |
| Last modified on | 2022/12/20 20:28:56 |
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Basic information
Public title
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
Acronym
Assessment of the efficacy and safety of accessory nerve reconstruction using nerve regeneration inducing tube in neck dissection- A Prospective Multicenter Clinical Study
Scientific Title
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
Scientific Title:Acronym
Assessment of the efficacy and safety of accessory nerve reconstruction using nerve regeneration inducing tube in neck dissection- A Prospective Multicenter Clinical Study
Region
| Japan |
Condition
Condition
Head and neck cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
the efficacy of accessory nerve reconstruction using nerve regeneration inducing tube (Nerbridge, TOYOBO CO., LTD. JAPAN) in neck dissection for patients with head and neck cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the active range of shoulder abductive motion at postoperative after 24 months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
accessory nerve reconstruction using nerve regeneration inducing tube in neck dissection
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Oridate |
Organization
Yokohama City University
Division name
Otorhinolaryngology, Head and Neck Surgery
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama city, 236-0004
TEL
045-787-2800
noridate@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Arai |
Organization
Yokohama City University
Division name
Otorhinolaryngology, Head and Neck Surgery
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama city, 236-0004
TEL
045-787-2800
Homepage URL
yasuarai@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
TOYOBO CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yokohama City University Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University
Address
3-9 Fukuura, Kanazawa-ku, Yokohama city, 236-0004
Tel
045-370-7627
nextjim1@yokohama-cu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 20 | Day |
Last modified on
| 2022 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035782
