Lymphatic Malformation
Conditions
Keywords
indocyanine green, children, inflow, lymphography
Brief summary
The goal of this prospective randomized controlled study is to explore the role of indocyanine green-fluorescence imaging in management of cystic lymphatic malformation.. To clarify the application value of indocyanine green-fluorescence imaging in both diagnosis and treatment of cystic lymphatic malformation (cLM) in children, is helpful for exploring pathogenesis of cLM, and providing a clearer scientific basis for subsequent surgical intervention. It also provides alternative for the future diagnosis and treatment of cLM. Participants will receive indocyanine green-fluorescence imaging before operation, while the patients in control group will receive traditional operation. Researchers will compare difference in curative effect between two groups.
Interventions
PROCEDUREInflow occlusion with perforation of septation and sclerotherapy
Inflow occlusion assisted by indocyanine green-fluorescence imaging combined with perforation of septation and sclerotherapy
PROCEDUREPerforation of septation and sclerotherapy
Perforation of septation and sclerotherapy
PROCEDUREIndocyanine green-guided partial resection and sclerotherapy
Indocyanine green-fluorescence imaging-guided partial resection and sclerotherapy
PROCEDUREPartial resection and sclerotherapy
Partial resection and sclerotherapy
Sponsors
Nanjing Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Days to 16 Years
Healthy volunteers
No
Inclusion criteria
(1) no previous intervention; (2) cLM diagnosed by pretreatment magnetic resonance imaging (MRI); (3)3 to 6 months post-treatment follow-up; (4) Superfacial cLM
Exclusion criteria
(1) history of iodine allergy; (2) syndromic cLM ; (3) severe liver and kidney dysfunction; (4) intralesional hemorrhage; (5) intralesional infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cure rate | 1month, 3 months | The percentage of cured cases to total cases |
| Effective rate | 1 month, 3 months | The percentage of effective cases to total cases |
| Treatment frequency | 3 months, 6 months | Frequency of treatments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Likert score | 6 months | Evaluation of postoperative satisfaction |
| Wound infection | 1 month | Infection of surgical region |
| Delayed healing | 1 month | Delayed healing of surgical wound |
| Pigmentation | 1 month | ICG-related pigmentation on skin |
Countries
China
Contacts
CONTACTTao Han, Dr.
STUDY_DIRECTORWeimin Shen, Dr.
Children's Hospital of Nanjing Medical University
Outcome results
None listed