UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025891
Receipt number R000029767
Scientific Title Prospective study on the effectiveness assessment of Indocyanine Green Lymphography and Lymphatic Surgery for lymphedema and lymphatic disease.
Date of disclosure of the study information 2017/02/01
Last modified on 2022/09/24 10:37:12

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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 Obstetrics 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 or person

Institute

Department of Lymphatic and Reconstructive Surgery, Saiseikai Kawaguchi General Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029767


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name