UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028236
Receipt number R000032319
Scientific Title Identification of subcutaneous lymph flow using navigation system and surgical support
Date of disclosure of the study information 2019/04/01
Last modified on 2020/01/21 12:32:21

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Basic information

Public title

Identification of subcutaneous lymph flow using navigation system and surgical support

Acronym

Identification of subcutaneous lymph flow using navigation system and surgical support

Scientific Title

Identification of subcutaneous lymph flow using navigation system and surgical support

Scientific Title:Acronym

Identification of subcutaneous lymph flow using navigation system and surgical support

Region

Japan


Condition

Condition

Chronic lymphedema, lymphatic malformations, lymphorrhea

Classification by specialty

Plastic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

When treating lymphedema, lymphorrhea, lymphangitis, lymphangioma, it is important to identify lymphatic vessels stuck up by examination. According to the conventional examination method, the lymph duct under the skin is predicted based on the image taken before surgery, skin incision is made at the time of operation, and the lymph duct is searched under direct vision. Many can identify lymph vessels by this method, but it is difficult to identify effective lymphatic vessels in some skin incisions and effective treatment is difficult. Therefore, investigate whether lymph duct identification rate improves by auxiliary use of navigation system in identifying lymph vessels.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Whether lymph ducts can be identified with skin incisions of 5 cm or less at multiple sites set using the navigation system

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Medicine Device,equipment

Interventions/Control_1

Use of navigation system

Interventions/Control_2

Conventional method without using navigation system

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

12 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Patients whose age ranges from 12 to 80
(2) Patients who are suspected of lymph flow abnormality by SPECT-CT lymphoscintigraphy
(3) Patients who are planning surgical treatment for the original disease

Key exclusion criteria

(1) Patients who did not shoot SPECT-CT lymphoscintigraphy
(2) Patients who can not obtain consent of surgical treatment
(3) Other patients judged inappropriate for judgment by doctor's judgment

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Maegawa Jiro

Organization

Yokohama City University, School of medicine

Division name

Department of Plastic and Recontsructive Surgery

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004

TEL

045-787-2709

Email

maegawaj@med.yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yabuki Yuichiro

Organization

Yokohama City University, School of medicine

Division name

Department of plastic and reconstructive surgery

Zip code


Address

Fukuura 3-9, Kanazawa-ku, Yokohama City, Kanagawa Prefecture

TEL

045-787-2709

Homepage URL


Email

yu1rou@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University

Institute

Department

Personal name



Funding Source

Organization

nothing

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2019 Year 04 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

About 10 cases were verified. The lymphatic duct identification rate was about 80% in the conventional treatment group not used, and about 95% in the navigation combined group.

Results date posted

2020 Year 01 Month 21 Day

Results Delayed

Delay expected

Results Delay Reason

Some of the results were posted and published in national journals. Currently, it is in the stage of accumulating targets and cases to be submitted to English-language journals.

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

Enrolling by invitation

Date of protocol fixation

2017 Year 03 Month 21 Day

Date of IRB

2017 Year 03 Month 21 Day

Anticipated trial start date

2017 Year 03 Month 21 Day

Last follow-up date

2022 Year 03 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 07 Month 14 Day

Last modified on

2020 Year 01 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032319


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name