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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Macro/mixed cystic lymphatic A | Experimental | Inflow occlusion assisted by indocyanine green-fluorescence imaging combined with perforation of septation and sclerotherapy |
|
| Macro/mixed cystic lymphatic B | Active Comparator | Perforation of septation and sclerotherapy |
|
| Microcystic lymphatic A | Experimental | Indocyanine green-fluorescence imaging-guided partial resection and sclerotherapy |
|
| Microcystic lymphatic B | Active Comparator | Partial resection and sclerotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inflow occlusion with perforation of septation and sclerotherapy | Procedure | Inflow occlusion assisted by indocyanine green-fluorescence imaging combined with perforation of septation and sclerotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Cure rate | The percentage of cured cases to total cases | 1month, 3 months |
| Effective rate | The percentage of effective cases to total cases | 1 month, 3 months |
| Treatment frequency | Frequency of treatments | 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Likert score | Evaluation of postoperative satisfaction | 6 months |
| Wound infection | Infection of surgical region | 1 month |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Han, Dr. | Contact | +86 186 5190 3495 | dr.hantao@njmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Weimin Shen, Dr. | Children's Hospital of Nanjing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's hospital of Nanjing medical university | Recruiting | Nanjing | Jiangsu | 210008 | China |
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| Perforation of septation and sclerotherapy | Procedure | Perforation of septation and sclerotherapy |
|
| Indocyanine green-guided partial resection and sclerotherapy | Procedure | Indocyanine green-fluorescence imaging-guided partial resection and sclerotherapy |
|
| Partial resection and sclerotherapy | Procedure | Partial resection and sclerotherapy |
|
| Delayed healing | Delayed healing of surgical wound | 1 month |
| Pigmentation | ICG-related pigmentation on skin | 1 month |
| ID | Term |
|---|---|
| D044148 | Lymphatic Abnormalities |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D015911 | Sclerotherapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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