UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031463 |
|---|---|
| Receipt number | R000035916 |
| Scientific Title | Investigation on pathological and biochemical changes and effects of surgery in patients with lymphedema |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2020/02/26 14:32:53 |
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Basic information
Public title
Investigation on pathological and biochemical changes and effects of surgery in patients with lymphedema
Acronym
Histological analysis of lymphedema
Scientific Title
Investigation on pathological and biochemical changes and effects of surgery in patients with lymphedema
Scientific Title:Acronym
Histological analysis of lymphedema
Region
| Japan |
Condition
Condition
lmphedema
Classification by specialty
| Surgery in general | Plastic surgery | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
At present, the normal of the confluent lymphatic vessels admitted during surgery is visually observed and clinically evaluated the severity of lymphedema, the extent of fibrosis of subcutaneous tissue, and the relation with surgical effect.
Basic objectives2
Others
Basic objectives -Others
To evaluate the residual specimen (lymph vessel, surrounding tissue, interstitial fluid) collected at the time of surgery, analyze the relationship between microstructural changes, biochemical change and clinical symptoms and postoperative course We will try to elucidate the pathology of lymphatic diseases including lymphedema and develop new treatments.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We examine the relationship between the data obtained in normal medical practice and the morphological changes and biochemical change of the residual specimen obtained at the time of surgery.
Only SF-36 is newly acquired for this research, and all other data are only existing information obtained by usual medical examination.
The specimens used for this study are only lymphatic vessels, surrounding tissues, and interstitial fluid that have become extra, usually discarded during surgery or treatment.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A case of lymphedema who was consulted at JR Tokyo General Hospital lymphatic surgery / reconstructive surgery
Key exclusion criteria
none
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | makoto |
| Middle name | none |
| Last name | Mihara |
Organization
JR Tokyo General Hospital
Division name
Lymphatic and Reconstructive Surgery
Zip code
1518528
Address
Yoyogi 2-1-3, Shibuya-ku, Tokyo, Japan
TEL
03-3320-2200
mihara.plasticsurgery@gmail.com
Public contact
Name of contact person
| 1st name | Yoshiko |
| Middle name | - |
| Last name | Hayashi |
Organization
JR Tokyo General Hospital
Division name
Pharmaceutical department
Zip code
1518528
Address
Yoyogi 2-1-3, Shibuya-ku, Tokyo, Japan
TEL
03-3320-2200
Homepage URL
06share09@jreast.co.jp
Sponsor or person
Institute
JR Tokyo General Hospital, Mihara Internal Medicine Clinic
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
JR Tokyo general hospital, Offce of Pharmacy
Address
Yoyogi 2-1-3, Shibuya-ku, Tokyo, Japan
Tel
03-3320-2200
06share09@jreast.co.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 01 | 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
1500
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
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The condition before and after the lymphatic surgery is evaluated by aggregation, VAS, volume alteration by tissue altitude, CT or MRI, lymphatic function evaluation by lymphatic penetration, and the like.
Management information
Registered date
| 2018 | Year | 02 | Month | 24 | Day |
Last modified on
| 2020 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035916
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
