UMIN-CTR Clinical Trial

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028236
Receipt No. 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 (Ver. 4)

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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
Institute Yokohama City University
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032319