UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010637 |
|---|---|
| Receipt number | R000012431 |
| Scientific Title | A randomised controlled study comparing vessel sealing system with conventional technique in axillary lymph node dissection for primary breast cancer |
| Date of disclosure of the study information | 2013/05/07 |
| Last modified on | 2016/11/03 10:27:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A randomised controlled study
comparing vessel sealing system with conventional technique in axillary lymph node dissection for primary breast cancer
Acronym
A randomised controlled study
comparing vessel sealing system with conventional technique in axillary lymph node dissection for primary breast cancer
Scientific Title
A randomised controlled study
comparing vessel sealing system with conventional technique in axillary lymph node dissection for primary breast cancer
Scientific Title:Acronym
A randomised controlled study
comparing vessel sealing system with conventional technique in axillary lymph node dissection for primary breast cancer
Region
| Japan |
Condition
Condition
Primary breast cancer
Classification by specialty
| Surgery in general | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of using vessel sealing system in axillary dissection for primary breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Duration until the axirally drainage volume reduced less than 30ml/day
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
vessel sealing system
Interventions/Control_2
convenstional technique
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
| 100 | years-old | > |
Gender
Female
Key inclusion criteria
1.Female patients pathologically diagnosed primary breast cancer
2.Patients with clinical T1-3 N0-2a M0
3.Patients with indication of axillary dissection
4.Patients expected for curative resection
Key exclusion criteria
1.Patients receiving surgery or radiation therapy in affected axilla in past
2.Patients with sever underlying disease
3.Anticoagulated patients
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kawakubo Hirohumi |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
35 Shinanomachi Shinjuku Tokyo 1608582 JAPAN
TEL
+813-33531211ext.62334
hkawakubo@z3.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsu Hayashida |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
35 Shinanomachi Shinjuku Tokyo 1608582 JAPAN
TEL
+813-33531211ext.62334
Homepage URL
tetsu@z7.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 02 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 27 | Day |
Date of closure to data entry
| 2015 | Year | 10 | Month | 27 | Day |
Date trial data considered complete
| 2015 | Year | 10 | Month | 27 | Day |
Date analysis concluded
| 2015 | Year | 10 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 02 | Day |
Last modified on
| 2016 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012431
