UMIN-CTR Clinical Trial

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

lymphedema

Classification by specialty

Surgery in general

Plastic surgery

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

prs_ycu@yokohama-cu.ac.jp

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

Email

prs_ycu@yokohama-cu.ac.jp

Institute

Yokohama City University

Institute

Department

Personal name

Organization

nothing

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

05

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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