UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031659 |
|---|---|
| Receipt number | R000035537 |
| Scientific Title | The efficacy of intraoperative neural monitoring for esophagectomy |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2020/09/09 10:55:41 |
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Basic information
Public title
The efficacy of intraoperative neural monitoring for esophagectomy
Acronym
IONM-E
Scientific Title
The efficacy of intraoperative neural monitoring for esophagectomy
Scientific Title:Acronym
IONM-E
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Morbidity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The rate of incidence of postoperative
laryngeal recurrent nerve palsy
Key secondary outcomes
Latency, Amplifier, Adverse effects
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 |
Interventions/Control_1
Recurrent laryngeal nerve monitoring by the nerve stimulation out of the art using Nerve Integrity Monitoring System (NIM)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient whom it was judged to need esophagectomy.
A patient with the intention according to a study enforcement plan.
About a trial entry, a patient signs the consent brief which caught the approval of the ethic screening committee of our examination enforcement medical institution.
Key exclusion criteria
Psychosis or psychiatric symptoms are merged and it is judged that it is difficult to participate in the exam.
The dangerously ill pathologic patient who judges that the study medical attendant is unsuitable for this study entry.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Uyama |
Organization
Fujita Health University
Division name
Department of digestive surgery
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, JAPAN
TEL
0565-93-9254
iuyama@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Shibasaki |
Organization
Fujita Health University
Division name
Department of digestive surgery
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, JAPAN
TEL
0565-93-9254
Homepage URL
susumushi48@mist.ocn.ne.jp
Sponsor or person
Institute
Fujita Health University,Department of digestive surgery
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University,Department of digestive surgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake-city, Aichi, Japan
Tel
0562-93-9254
f-irb@fujita-hu.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
藤田医科大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 09 | 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 | 09 | Day |
Last modified on
| 2020 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035537
