UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031819 |
|---|---|
| Receipt number | R000036342 |
| Scientific Title | Clinical study of continuous intraoperative vagus nerve stimulation for monitoring function of recurrent laryngeal nerve during esophagectomy for esophageal cancer |
| Date of disclosure of the study information | 2018/03/20 |
| Last modified on | 2019/03/26 21:23:42 |
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Basic information
Public title
Clinical study of continuous intraoperative vagus nerve stimulation for monitoring function of recurrent laryngeal nerve during esophagectomy for esophageal cancer
Acronym
Monitoring RLN function during esophageal cancer surgery
Scientific Title
Clinical study of continuous intraoperative vagus nerve stimulation for monitoring function of recurrent laryngeal nerve during esophagectomy for esophageal cancer
Scientific Title:Acronym
Monitoring RLN function during esophageal cancer surgery
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Procedures of lymph node dissection around the recurrent laryngeal nerves and the postoperative recurrent laryngeal nerve palsy are analyzed and the high quality procedure is established using continuous intraoperative vagus nerve stimulation for monitoring function of recurrent laryngeal nerve in order to reduce the incidence and grade of the postoperative nerve palsy in esophageal cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
vocal cord movement
Key secondary outcomes
hoarseness, aspiration, pneumonia
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
An EMG endotracheal tube is used. The nerve function is continuously monitored using NIM-Response 3.0 with APS equipped on the vagus nerve electrode once an operation.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients esophageal caner who plan for the elective surgeries.
2) Patients with signed informed consent.
Key exclusion criteria
1) Patients with impaired judgement.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Soji |
| Middle name | |
| Last name | Ozawa |
Organization
Tokai University School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa, 259-1193 Japan
TEL
0463-93-1121
sozawa@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Soji |
| Middle name | |
| Last name | Ozawa |
Organization
Tokai University School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa, 259-1193 Japan
TEL
0463-93-1121
Homepage URL
tokai.eso@tokai-u.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Institutional Review Board for Clinical Research, Tokai University Hospital
Address
143 Shimokasuya, Isehara City, Kanagawa
Tel
0463931121
tokai-rinsho@ml.tokai-u.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
東海大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | 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
| 2017 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 27 | Day |
Last follow-up date
| 2021 | 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 | 03 | Month | 20 | Day |
Last modified on
| 2019 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036342
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
