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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
