UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study of lymphaticovenular anastomosis for generalized lymphatic dysplasia
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yukio Seki
Organization	St. Marianna Graduate School of Medicine
Division name	Department of Plastic and Reconstructive Surgery
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan
TEL	0449778111
Email	seki-pla@marianna-u.ac.jp

Public contact
Name of contact person	Yukio Seki
Organization	St. Marianna Graduate School of Medicine
Division name	Department of Plastic and Reconstructive Surgery
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan
TEL	0449778111
Homepage URL
Email	seki-pla@marianna-u.ac.jp

Sponsor
Institute	St. Marianna Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 05 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025866