UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Usefulness of intraoperative nerve monitoring in predicting postoperative recurrent laryngeal nerve palsy in esophageal cancer surgery
Title of the study (Brief title)	Intraoperative recurrent laryngeal nerve monitoring
Region	Japan

Condition
Condition	esophagealcancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To reveal the usefulness of intraoperative nerve monitoring in predicting postoperative recurrent laryngeal nerve palsy
Basic objectives2	Others
Basic objectives -Others	To reveal the usefulness of intraoperative nerve monitoring in predicting the severity of postoperative recurrent laryngeal nerve palsy
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The relationship between the amplitude of electromyogram and the occurence of postoperative vocal cord palsy
Key secondary outcomes	The relationship between the amplitude of electromyogram and the occurence of persistent vocal cord palsy

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Use of intraoperative nerve monitor The vagus and recurrent laryngeal nerves are stimulated with the current of 1mA for 3 seconds after lymph node dissection
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who undergo esophagectomy with 3 field lymph node dissection for esophageal cancer
Key exclusion criteria	Patients with preoperative recurrent laryngeal nerve palsy
Target sample size	40

Research contact person
Name of lead principal investigator	Yuichiro Doki
Organization	Osaka university
Division name	Surgery
Address	2-2 Yamadaoka,Suitashi,Osaka
TEL	0668793251
Email	ydoki@gesurg.med.osala-u.ac.jp

Public contact
Name of contact person	Takashi Kanemura
Organization	Osaka university
Division name	Surgery
Address	2-2 Yamadaoka,Suitashi,Osaka
TEL	0668793251
Homepage URL
Email	kanemura@tonbyo.org

Sponsor
Institute	Osaka university
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Osaka university
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 12 Day
Anticipated trial start date	2013 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 12 Day
Last modified on	2016 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026164