UMIN-CTR Clinical Trial

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
Email	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
Email	susumushi48@mist.ocn.ne.jp

Sponsor
Institute	Fujita Health University,Department of digestive surgery
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035537