UMIN-CTR Clinical Trial

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
Email	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
Email	kibk9925@gmail.com

Sponsor
Institute	University of Toyama
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050467