UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026899 |
|---|---|
| Receipt number | R000030859 |
| Scientific Title | Observation and evaluation of skin and subcutaneous tissue using ultrasonic examination equipment for lymphedema |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2020/01/21 13:47:16 |
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Basic information
Public title
Observation and evaluation of skin and subcutaneous tissue using ultrasonic examination equipment for lymphedema
Acronym
Observation and evaluation of skin and subcutaneous tissue using ultrasonic examination equipment for lymphedema
Scientific Title
Observation and evaluation of skin and subcutaneous tissue using ultrasonic examination equipment for lymphedema
Scientific Title:Acronym
Observation and evaluation of skin and subcutaneous tissue using ultrasonic examination equipment for lymphedema
Region
| Japan |
Condition
Condition
lymphedema
Classification by specialty
| Surgery in general | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main purpose of this research is to use ultrasonic examination equipment with high versatility and widely used to early diagnosis, severity assessment, treatment effect judgment of patients with limb lymphedema, ultrasonic It is to prepare appropriate criteria for limb lymphedema by test equipment. If this demonstrates the usefulness of mild ultrasonography of invasion of lymphedema, this will lead to reducing the physical and mental burden of the patient in routine practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
From the consent acquisition until the end of the research period, obtain the following image findings. Simple ultrasound examination (B mode): presence / absence of boundary line at lower edge of dermis, continuity of fascia. Simple ultrasonography (elastography): Hardness of subcutaneous tissue.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
1. We performed lymphoscintigraphy (SPECT / CT) or ICG fluorescence lymphangiography according to our protocol on patients with chronic lymphedema of the extremity who had visited Yokohama City University Department of Plastic Surgery to classify the severity of lymphatic dysfunction . After acquiring consent for participation in this study, we confirm that all selection criteria are met and whether any of exclusion criteria are not met, and patients who satisfy the conditions are registered as research subjects.
2. I will listen to the subjects for physical clinical severity (circumference, volume, frequency of inflammation etc.) about lymphoedema, timing of onset of edema, years since onset, past treatment history etc.
3. Determine the content of conservative treatment according to severity of lymph dysfunction.
4. Evaluate the following items with ultrasonic inspection equipment before the start of preservative treatment and at the time when the content of preserved preservative treatment is reached.
* Observe the skin and subcutaneous tissue in standard mode and observe the thickness measurement and change in brightness.
* Evaluate hardness change of tissue before and after treatment by using mode for evaluating hardness such as elastography and shea wave.
5. Scheduled preservation After reaching the treatment, if there is hope from the research subject, lymph venous anastomosis is performed. Among patients who underwent surgical treatment, in cases where consent on donation of subcutaneous and lymphatic vessels was obtained in a study different from this study, examination of correlation and correlation between pathological findings and ultrasonic image findings As well.
Interventions/Control_2
1. Volunteers for healthy volunteers will be publicly invited on our homepage.
2. After acquiring consent for participation in this study, we confirm that all selection criteria are met and whether any of exclusion criteria are not met, and healthy volunteers meeting the conditions are registered as research subjects.
3. Evaluate the following items with ultrasonic inspection equipment.
* Observe the skin and subcutaneous tissue in standard mode and observe the thickness measurement and change in brightness.
* Evaluate the hardness of tissue using a mode for evaluating hardness such as elastography and shea wave.
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
| 0 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with limb lymphedema by lymphoscintigraphy or ICG fluorescence lymphangiography
2. Patients who are 0 to 80 years of age at the time of registration do not matter in sex.
3. Whether or not treatment history for limb lymphoedema is present does not matter.
Four. Patients with systolic blood pressure less than 160 mm Hg and diastolic blood pressure less than 100 mm Hg (internal control possible)
5. Patients with severe heart disease or lung disease
6. Uncontrollable diabetic patients (with or without treatment) with a fasting blood sugar level of 130 mg / dL or more
7. In addition, patients judged unsuitable as subjects by doctor's judgment
Key exclusion criteria
1. Patients with a history of hypersensitivity to the drugs used
2. Patients allergic to eggs and egg products
3. Patients who are pregnant, may be pregnant, or prefer pregnancy during treatment. Breastfeeding patients
Four. Patients with right and left shunts in the heart and lungs
5. Patients with severe heart disease or lung disease
6. Uncontrollable diabetic patients (with or without treatment) with a fasting blood sugar level of 130 mg / dL or more
7. In addition, patients judged unsuitable as subjects by doctor's judgment
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Maegawa Jiro |
Organization
Yokohama City University, School of medicine
Division name
Department of plastic and reconstructive surgery
Zip code
Address
Fukuura 3-9, Kanazawa-ku, Yokohama City, Kanagawa Prefecture
TEL
045-787-2709
prs_ycu@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maegawa Jiro |
Organization
Yokohama City University, School of medicine
Division name
Department of plastic and reconstructive surgery
Zip code
Address
Fukuura 3-9, Kanazawa-ku, Yokohama City, Kanagawa Prefecture
TEL
045-787-2709
Homepage URL
prs_ycu@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 05 | 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
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
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 07 | Day |
Last modified on
| 2020 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030859
