UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study on the effectiveness assessment of Indocyanine Green Lymphography and Lymphatic Surgery for lymphedema and lymphatic disease.
Acronym	Prospective study on the effectiveness assessment of Indocyanine Green Lymphography and Lymphatic Surgery for lymphedema and lymphatic disease.
Scientific Title	Prospective study on the effectiveness assessment of Indocyanine Green Lymphography and Lymphatic Surgery for lymphedema and lymphatic disease.
Scientific Title:Acronym	Prospective study on the effectiveness assessment of Indocyanine Green Lymphography and Lymphatic Surgery for lymphedema and lymphatic disease.
Region	Japan

Condition
Condition	Lymphedema and lymphatic disease
Classification by specialty	Surgery in general Obsterics and gynecology Plastic surgery Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Using indocyanine green lymphography to investigate the pathology and the effectiveness of surgical remedies in lymphedema patients by analyzing pre-, intra-, and post-operative lymphatic assessments, comparing pre and postoperative changes, and assessing the associated clinical symptoms. In this study, we investigate the difference in the effectiveness of end-to-end anastomosis and end-to-side anastomosis in lymph vessel venous anastomosis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	We analyze the assesment pre-operation and every 6 month. Patient chart (name, patient ID, clinical history, pre and postoperative course, limb circumference, tissue stiffness); echogram, CT, MRI, lymphoscintigraphy, indocyanine green lymphography, and lymphoangiography obervations; blood test (complete blood count, chemistry, coagulation, blood type); histopathological analysis (collecting lymphatic vessel, adipose tissue, skin tissue, etc.); clinical photography (bilateral upper limbs for upper limb edema, bilateral lower limbs, abdominal, and inguinal area for lower limb lymphedema); health-related QOL analysis using Short Form (SF)-36 Health Survey; patient weight; general physical and image observations.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Indocyanine green (ICG) lymphography and Lymphatic venous anastomosis(LVA)
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	1) Saitamaken Saiseikai Kawaguchi General Hospital Patients who received lymphatic surgery / reconstructive surgery 2) Patients diagnosed with secondary lower extremity lymphoedema by lymphoscintigraphy 3) Patients judged to have the ability to answer interrogation 4) Patients who obtained document consent by the patients themselves freely with sufficient understanding after receiving sufficient explanation for participation in this study. 5) In cases where the patient is a minor, 4) In addition to the patient caregiver sufficient understanding, document consent is obtained.
Key exclusion criteria	Exclusion criteria Patients who conflict with the following criteria shall not be included in this study. 1) Patients with postoperative observation period of less than 6 months 2) Patients with complication of edema due to heart failure / renal failure etc. 3) Cases judged inappropriate by test doctor
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Mihara
Organization	Saiseikai Kawaguchi General Hospital
Division name	Lymphatic and Reconstructive Surgery
Zip code	332-8558
Address	5-11-5 Nishikawaguchi, Kawaguchi-shi, Saitama, Japan
TEL	048-253-1551
Email	mihara.plasticsurgery@gmail.com

Public contact
Name of contact person	1st name Yoshinori Middle name Last name Shimizu
Organization	Saiseikai Kawaguchi General Hospital
Division name	Financial and legal department
Zip code	332-8558
Address	5-11-5 Nishikawaguchi, Kawaguchi-shi, Saitama, Japan
TEL	048-253-1551
Homepage URL
Email	zaimuhoumu@saiseikai.gr.jp

Sponsor
Institute	Department of Lymphatic and Reconstructive Surgery, Saiseikai Kawaguchi General Hospital
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	Saiseikai Kawaguchi General Hospital
Address	Nishi-kawaguchi 5-11-5, Kawaguchi-shi, Saitamaken, Japan
Tel	048-253-1551
Email	zaimuhoumu@saiseikai.gr.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	済生会川口総合病院（埼玉県）

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 01 Day

Related information
URL releasing protocol	https://www.mominoki-shinryosho.jp/cellulitis/evidence/
Publication of results	Unpublished

Result
URL related to results and publications	https://www.mominoki-shinryosho.jp/cellulitis/evidence/
Number of participants that the trial has enrolled	220
Results	Preparing data
Results date posted	2022 Year 09 Month 24 Day
Results Delayed	Delay expected
Results Delay Reason	Preparing data
Date of the first journal publication of results
Baseline Characteristics	Preparing data
Participant flow	Preparing data
Adverse events	Preparing data
Outcome measures	Preparing data
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 29 Day
Date of IRB	2015 Year 01 Month 01 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2019 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 01 Month 29 Day
Last modified on	2022 Year 09 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029767