UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022446 |
|---|---|
| Receipt number | R000025866 |
| Scientific Title | Clinical study of lymphaticovenular anastomosis for generalized lymphatic dysplasia |
| Date of disclosure of the study information | 2016/05/25 |
| Last modified on | 2016/05/25 11:44:44 |
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Basic information
Public title
Clinical study of lymphaticovenular anastomosis for generalized lymphatic dysplasia
Acronym
Lymphaticovenular anastomosis for generalized lymphatic dysplasia in infants with chylothorax and chylous ascites
Scientific Title
Clinical study of lymphaticovenular anastomosis for generalized lymphatic dysplasia
Scientific Title:Acronym
Lymphaticovenular anastomosis for generalized lymphatic dysplasia in infants with chylothorax and chylous ascites
Region
| Japan |
Condition
Condition
generalized lymphatic dysplasia,lymphedema in infants
Classification by specialty
| Pediatrics | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Improvement of congenital chylothorax and chylous ascites with generalized lymphatic dysplasia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
severity of lymphedema including amount of chylothorax and chylous ascites
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Lymphaticovenular anastomosis
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
| 51 | days-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. 51-day-old and over
2. clinically suspected generalized lymphatic dysplasia
3. conservative therapy including drug therapy is not effective
4. drainage of chylothorax and chylous ascites is not effective
5. thoracic-abdominal shunt is not effective
6. perioperative management in neonatal intensive care unit is possible
7. patient's condition tolerates surgery under general anesthesia
8. surviving over 3 months can be difficult with common treatments
9. patients with writtend concent
Key exclusion criteria
1. spontaneous improvement is expected
2. patients with drug allergy for the treatment is suspected
3. patients with severe infection
4. surviving over 6 months can be difficult with other underlying disorders
5. when the investigator judged that a patient is not appropriate for participant in ohter reasons
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukio Seki |
Organization
St. Marianna Graduate School of Medicine
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan
TEL
0449778111
seki-pla@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukio Seki |
Organization
St. Marianna Graduate School of Medicine
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan
TEL
0449778111
Homepage URL
seki-pla@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna Graduate School of Medicine
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
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
| 2016 | Year | 05 | Month | 25 | 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
Results date posted
Results Delayed
Results Delay Reason
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
| 2016 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 25 | Day |
Last modified on
| 2016 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025866
