UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004036
Receipt number 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 13:29:47

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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 or person

Institute

Keio University, School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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