UMIN-CTR Clinical Trial

Basic information
Public title	Investigation on pathological and biochemical changes and effects of surgery in patients with lymphedema
Acronym	Histological analysis of lymphedema
Scientific Title	Investigation on pathological and biochemical changes and effects of surgery in patients with lymphedema
Scientific Title:Acronym	Histological analysis of lymphedema
Region	Japan

Condition
Condition	lmphedema
Classification by specialty	Surgery in general Plastic surgery Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	At present, the normal of the confluent lymphatic vessels admitted during surgery is visually observed and clinically evaluated the severity of lymphedema, the extent of fibrosis of subcutaneous tissue, and the relation with surgical effect.
Basic objectives2	Others
Basic objectives -Others	To evaluate the residual specimen (lymph vessel, surrounding tissue, interstitial fluid) collected at the time of surgery, analyze the relationship between microstructural changes, biochemical change and clinical symptoms and postoperative course We will try to elucidate the pathology of lymphatic diseases including lymphedema and develop new treatments.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We examine the relationship between the data obtained in normal medical practice and the morphological changes and biochemical change of the residual specimen obtained at the time of surgery. Only SF-36 is newly acquired for this research, and all other data are only existing information obtained by usual medical examination. The specimens used for this study are only lymphatic vessels, surrounding tissues, and interstitial fluid that have become extra, usually discarded during surgery or treatment.
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	A case of lymphedema who was consulted at JR Tokyo General Hospital lymphatic surgery / reconstructive surgery
Key exclusion criteria	none
Target sample size	1500

Research contact person
Name of lead principal investigator	1st name makoto Middle name none Last name Mihara
Organization	JR Tokyo General Hospital
Division name	Lymphatic and Reconstructive Surgery
Zip code	1518528
Address	Yoyogi 2-1-3, Shibuya-ku, Tokyo, Japan
TEL	03-3320-2200
Email	mihara.plasticsurgery@gmail.com

Public contact
Name of contact person	1st name Yoshiko Middle name - Last name Hayashi
Organization	JR Tokyo General Hospital
Division name	Pharmaceutical department
Zip code	1518528
Address	Yoyogi 2-1-3, Shibuya-ku, Tokyo, Japan
TEL	03-3320-2200
Homepage URL
Email	06share09@jreast.co.jp

Sponsor
Institute	JR Tokyo General Hospital, Mihara Internal Medicine Clinic
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	JR Tokyo general hospital, Offce of Pharmacy
Address	Yoyogi 2-1-3, Shibuya-ku, Tokyo, Japan
Tel	03-3320-2200
Email	06share09@jreast.co.jp

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	2018 Year 03 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	1500
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	2018 Year 02 Month 01 Day
Date of IRB	2018 Year 02 Month 01 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The condition before and after the lymphatic surgery is evaluated by aggregation, VAS, volume alteration by tissue altitude, CT or MRI, lymphatic function evaluation by lymphatic penetration, and the like.

Management information
Registered date	2018 Year 02 Month 24 Day
Last modified on	2020 Year 02 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035916