UMIN-CTR Clinical Trial

Basic information
Public title	Trial of recurrent laryngeal nerve monitoring during radical esophagectomy for prevention of nerve palsy
Acronym	Trial of recurrent laryngeal nerve monitoring during radical esophagectomy for prevention of nerve palsy
Scientific Title	Trial of recurrent laryngeal nerve monitoring during radical esophagectomy for prevention of nerve palsy
Scientific Title:Acronym	Trial of recurrent laryngeal nerve monitoring during radical esophagectomy for prevention of nerve palsy
Region	Japan

Condition
Condition	Esophageal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Prospective study of evaluation of preventive effects for recurrent laryngeal nerve palsy with electrical nerve monitoring during radical esophagectomy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of recrrent laryngeal nerve palsy after radical esophagectomy
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 Maneuver
Interventions/Control_1	Electrical recurrent laryngeal nerve monitoring during radical esophagectomy
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	Patient undergoing radical surgery for esphageal cancer meet following criteria: 1) Resectable disease 2) Clinical stage I, II or III excluding T4b disease (UICC tumor, node, metastasis system TNM classification) 3) Age 20 to 80 years 4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 5) No previous surgery for esophageal cancers 6) No previous chemo- or radiotherapy for any malignancies 7) Sufficient organ function 8) Written informed consent
Key exclusion criteria	1) Other primary cancer 2) Psychiatric disease 3) Serious complications 4) Cardiovascular disease or heart failure occur within 3 months 5) Cerebrovascular disease occur within 3 months 6) Active infection 7) With cardiac pacemaker or defibrillator 8) Positive for hepatitis B virus antigen 9) Pregnancy 10) Others who are inadequate to entry this study
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Hikage
Organization	Tohoku University Hospital
Division name	Department of Advanced Surgical Science and Technology
Zip code	980-8574
Address	Seiryo-machi 1-1, Aoba-ku, Sendai 980-8574, Japan
TEL	022-717-7214
Email	mhikage@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Hikage
Organization	Tohoku University Hospital
Division name	Department of Advanced Surgical Science and Technology
Zip code	980-8574
Address	Seiryo-machi 1-1, Aoba-ku, Sendai 980-8574, Japan
TEL	022-717-7214
Homepage URL
Email	mhikage@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital
Institute
Department

Funding Source
Organization	JSPS
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Tohoku University Hospital
Address	Seiryo-machi 1-1, Aoba-ku, Sendai 980-8574, Japan
Tel	022-728-4105
Email	rinri-2@proj.med.tohoku.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	東北大学病院（宮城県）

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 02 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	Main results already published
Date of protocol fixation	2014 Year 02 Month 18 Day
Date of IRB	2014 Year 02 Month 18 Day
Anticipated trial start date	2014 Year 03 Month 01 Day
Last follow-up date	2019 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	2015 Year 05 Month 02 Day
Last modified on	2020 Year 11 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020178