UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022706 |
|---|---|
| Receipt number | R000026164 |
| Scientific Title | Usefulness of intraoperative nerve monitoring in predicting postoperative recurrent laryngeal nerve palsy in esophageal cancer surgery |
| Date of disclosure of the study information | 2016/06/12 |
| Last modified on | 2016/06/12 12:42:19 |
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Basic information
Public title
Usefulness of intraoperative nerve monitoring in predicting postoperative recurrent laryngeal nerve palsy in esophageal cancer surgery
Acronym
Intraoperative recurrent laryngeal nerve monitoring
Scientific Title
Usefulness of intraoperative nerve monitoring in predicting postoperative recurrent laryngeal nerve palsy in esophageal cancer surgery
Scientific Title:Acronym
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
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
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
| 1st name | |
| Middle name | |
| Last name | Yuichiro Doki |
Organization
Osaka university
Division name
Surgery
Zip code
Address
2-2 Yamadaoka,Suitashi,Osaka
TEL
0668793251
ydoki@gesurg.med.osala-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Kanemura |
Organization
Osaka university
Division name
Surgery
Zip code
Address
2-2 Yamadaoka,Suitashi,Osaka
TEL
0668793251
Homepage URL
kanemura@tonbyo.org
Sponsor or person
Institute
Osaka university
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 12 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026164
