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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031819
Receipt No. 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

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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
Email 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
Email tokai.eso@tokai-u.jp

Sponsor
Institute Tokai University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036342

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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