UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the lymphedema improvement with the surgical combination therapy for secondary limbs lymphedema
Title of the study (Brief title)	Examination of the lymphedema improvement with the surgical combination therapy
Region	Japan

Condition
Condition	Lymphedema
Classification by specialty	Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We determine improvement with the surgical combination therapy for lymphedema
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Limbs circumference, ICG fluorescent lymphography, SF36
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Vasculized lymph node transfer(VLNT)
Interventions/Control_2	Vasculized lymph node transfer, Lymphaticovenuler anastomosis(LVA)
Interventions/Control_3	Lymphaticovenuler anastomosis
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients who there is secondary lymphedema, and expect surgical cure. The person who is available for LVA conducts LVA by ICG lymphangiography. The person with the LVA treatment resistance receives LNT or VLNT+LVA.
Key exclusion criteria	Those whom we considre inappropiate due to physical and/or mental problem
Target sample size	50

Research contact person
Name of lead principal investigator	Yukiko Kuramoto
Organization	Cancer Institute Hospital
Division name	Department of Plastic and Reconstructive Surgery
Address	3-8-31 Ariake, Koutou-ku, Tokyo, 135-8550 Japan
TEL	03-3520-0111
Email	yukiko.kuramoto@jfcr.or.jp

Public contact
Name of contact person	Yukiko Kuramoto
Organization	Cancer Institute Hospital
Division name	Department of Plastic and Reconstructive Surgery
Address	3-8-31 Ariake, Koutou-ku, Tokyo, 135-8550 Japan
TEL	03-3520-0111
Homepage URL
Email	yukiko.kuramoto@jfcr.or.jp

Sponsor
Institute	Cancer Institute Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Cancer Institute Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2016 Year 06 Month 30 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 06 Month 04 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 10 Day
Last modified on	2016 Year 06 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026154