UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007744 |
|---|---|
| Receipt number | R000009118 |
| Scientific Title | Relationship of extended upper mediastinal lymphadenectomy for esophageal cancer and recurrent laryngeal nerve palsy: a prospective study |
| Date of disclosure of the study information | 2012/04/13 |
| Last modified on | 2015/04/02 09:16:04 |
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Basic information
Public title
Relationship of extended upper mediastinal lymphadenectomy for esophageal cancer and recurrent laryngeal nerve palsy: a prospective study
Acronym
lymphadenectomy for esophageal cancer and recurrent laryngeal nerve palsy
Scientific Title
Relationship of extended upper mediastinal lymphadenectomy for esophageal cancer and recurrent laryngeal nerve palsy: a prospective study
Scientific Title:Acronym
lymphadenectomy for esophageal cancer and recurrent laryngeal nerve palsy
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery | Oto-rhino-laryngology | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate the relationship between the relationship of extended upper mediastinal lymphadenectomy and recurrent laryngeal nerve palsy in patients who underwent surgery for esophageal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of recurrent laryngeal nerve palsy
Key secondary outcomes
Overall survival, relapse-free survival and incidence of complication
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Esophagectomy without extended upper mediastinal lymphadenectomy
Interventions/Control_2
Esophagectomy with extended upper mediastinal lymphadenectomy
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
(1) histologically proven adenocarcinoma
(2) age 20-79 years
(3) sufficient organ function
Key exclusion criteria
(1) Any patients judged to be unfit to participate in the study, by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruhiro Inoue, MD, PhD |
Organization
Showa University Koto Toyosu Hospital
Division name
Digestive Disease Center
Zip code
Address
5-1-38 Toyosu, Koto-ku, Tokyo 135-8577, Japan
TEL
03-6204-6000
haruinoue777@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruhiro Inoue, MD, PhD |
Organization
Showa University Koto Toyosu Hospital
Division name
Digestive Disease Center
Zip code
Address
5-1-38 Toyosu, Koto-ku, Tokyo 135-8577, Japan
TEL
03-6204-6000
Homepage URL
haruinoue777@yahoo.co.jp
Sponsor or person
Institute
Digestive Disease Center, Showa University Koto Toyosu Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2012 | Year | 04 | Month | 13 | 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
| 2012 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | 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
| 2012 | Year | 04 | Month | 13 | Day |
Last modified on
| 2015 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009118
