UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044195 |
|---|---|
| Receipt number | R000050467 |
| Scientific Title | The evaluation of transcatheter interventions for lymphatic complications after surgical repair in the patients with congenital heart disease. |
| Date of disclosure of the study information | 2021/05/20 |
| Last modified on | 2021/05/12 23:29:06 |
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Basic information
Public title
The evaluation of transcatheter interventions for lymphatic complications after surgical repair in the patients with congenital heart disease.
Acronym
The evaluation of transcatheter interventions for lymphatic complications after surgical repair in the patients with congenital heart disease.
Scientific Title
The evaluation of transcatheter interventions for lymphatic complications after surgical repair in the patients with congenital heart disease.
Scientific Title:Acronym
The evaluation of transcatheter interventions for lymphatic complications after surgical repair in the patients with congenital heart disease.
Region
| Japan |
Condition
Condition
protein losing enteropathy, plastic bronchitis, chylothorax
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the safety and efficacy of transcatheter interventions for the lymphatic complications after surgery for congenital heart disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
serum albumin, clinical symptoms, complications
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
transcatheter lymph embolization
We perform the procedure under general anesthesia in cath labo or hybrid operation room. We embolize the abnormal lymph duct with lipid soluble contrast or n butyl-2-cyanoacrylate.
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
patients with refractory protein losing enteropathy, plastic bronchitis and chylothorax after surgery for congenital heart disease
Key exclusion criteria
patients with active bleeding, infection or allergy to lipid soluble contrast and n butyl-2-cyanoacrylate.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Keijiro |
| Middle name | |
| Last name | Ibuki |
Organization
University of Toyama
Division name
The devision of pediatrics
Zip code
930-0194
Address
2630 Sugitani Toyama city, Toyama
TEL
076-434-7313
kibk9925@gmail.com
Public contact
Name of contact person
| 1st name | Keijiro |
| Middle name | |
| Last name | Ibuki |
Organization
University of Toyama
Division name
The devision of pediatrics
Zip code
930-0194
Address
2630 Sugitani Toyama city, Toyama
TEL
076-434-7313
Homepage URL
kibk9925@gmail.com
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
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
University of Toyama
Address
2630 Sugitani Toyama city, Toyama
Tel
076-434-7313
kibk9925@gmail.com
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
| 2021 | Year | 05 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2021 | Year | 05 | Month | 12 | Day |
Last modified on
| 2021 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050467
