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Recruitment status Terminated
Unique ID issued by UMIN UMIN000004036
Receipt No. R000004857
Scientific Title Rehabilitation for secondary lymphedema of lower limbs Lymphatic transportation measurement with ICG lymphography and the effect of rehabilitation
Date of disclosure of the study information 2010/09/01
Last modified on 2014/08/13

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Basic information
Public title Rehabilitation for secondary lymphedema of lower limbs
Lymphatic transportation measurement with ICG lymphography and the effect of rehabilitation
Acronym Rehabilitation and ICG lymphography for secondary lymphedema of lower limbs
Scientific Title Rehabilitation for secondary lymphedema of lower limbs
Lymphatic transportation measurement with ICG lymphography and the effect of rehabilitation
Scientific Title:Acronym Rehabilitation and ICG lymphography for secondary lymphedema of lower limbs
Region
Japan

Condition
Condition Secondary lymphedema
Classification by specialty
Vascular surgery Plastic surgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the ability of lymphatic transportation and the effect of rehabilitation using ICG lymphography for secondary lymphedema
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes 1.function of lymphatic transportation
2. image of ICG lymphography
Key secondary outcomes 1.diameter of lower limb
2.thickness of skin tissue
3.sepecific symptoms related to lymphedema

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Method of ICG lymphography
1) supine position at rest(10 minutes).
2) Subcutaneous infusion of the dorsum of foot with 0.5ml of 1% Xylocain with a 29-gauge needle.
3) Bandage-like compression of a lower leg (Manchette compression is applied at 70 mmHg with a sphygmomanometer).
4) Subcutaneous infusion of the dorsum of foot with 0.3ml. of 5% ICG (indocyanine green) solution with a 29-gauge needle.
5) Imaging of lymphatic vessel using an infrared camera system (PDE, Hamamatsu Photonics).
6) Rubbing an injection part lightly and guide ICG in lymphatic vessel.
7) Measurement of the minimal pressure which inhibit to start flowing ICG (Manchette compression is reduced by 10mmHg every 3 minutes (minimal inhibition pressure).
8) Measurement of the time to transport ICG from injected site to knee or inguinal area (transit time).
9) Scoring of the specific image of ICG lymphography (dermal back flow, local dilatation, stoppage and expansion meandering, diffuse and scattering signal).

Evaluation of reliability
Confirming the reproducibility of the ICG lymphography using Intraclass Correlation (ICC) between two measurements at an interval of two weeks or more.

Evaluation of change over time
If necessary, the ICG lymphography is performed before and 1, 2, 3 and 6 months after pelvic lynphadenectomy.

Interventions/Control_2 Evaluation of validity
1) Measurement of the leg lap diameter (above knee 20cm and 10cm, below knee 10cm and 20cm, ankle, dorsum of foot).
2) Measurement of the subcutaneous tissue thickness using the ultrasonic echo.
3) Collecting demographic data, physical examination (height, weight, Body mass index, age, sex, history of operation, treatment career of the past, current treatment contents, a period to the lymphoedema onset, the degree of the pressure trace, degree of the skin hardening, Clinical stage scale for classification of a lymphedematous limb)
4) Statistical analysis of the correlation between clinical data and transit time, minimal inhibition pressure, and specific image of ICG lymphography.
Interventions/Control_3 Exercise load
We measure the transit time between baseline and after 5 min knee flexion-extension exercise.
Interventions/Control_4 Rehabilitation (Lymph drainage)
We measure the transit time between baseline and after 20 min rehabilitation(manual lymph drainage by physical therapist).
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 Female
Key inclusion criteria 1. secondary lymphedema
2. lymphedema of lower limb
3. caused by uterus cancer, ovarian cancer and their therapies
Key exclusion criteria 1.phlegmonitis
2.leakage of lymphatic fluid
3.deep venous thrombosis and sever aneurysm
4.poor general status(Performance Status 3 or more)
5.acute generalized inflammation and fever(38.0 centidegree or more)
6.severe heart failure
7.pulmonary embolism, acute respiratory failure, severe pulmonary hypertension
8.severe hepatic and renal failure
9.severe mental disorder, sever psychological diseases
10.other metabolic disorders (acute thyroiditis etc.)
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Tsuji
Organization Keio University, School of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan
TEL 03-5363-3833
Email cxa01423@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Taro Okitsu
Organization Keio University, School of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan
TEL 03-5363-3833
Homepage URL
Email PXW13537@nifty.com

Sponsor
Institute Keio University, School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology Training for Oncology Professionals in 9 universities
(in 2010)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2010 Year 09 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 Terminated
Date of protocol fixation
2010 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
2014 Year 07 Month 31 Day
Date of closure to data entry
2014 Year 07 Month 31 Day
Date trial data considered complete
2014 Year 07 Month 31 Day
Date analysis concluded
2014 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 08 Month 12 Day
Last modified on
2014 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004857

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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