An interventional study of Inflow occlusion with perforation of septation and sclerotherapy and Perforation of septation and sclerotherapy in Lymphatic Malformation, sponsored by Nanjing Children's Hospital. Recruiting at 1 site in China. Open to participants aged 30 Days to 16 Years. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by Nanjing Children's Hospital · Not applicable, Interventional, and Treatment
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.
42 studies on the registry are indexed under Lymphatic Abnormalities; 17 are open to participants now.
This study's planned enrollment of 110 is above the median of 46 across 28 interventional studies indexed under Lymphatic Abnormalities.
Browse Lymphatic Abnormalities studies →Nanjing Children's Hospital is the lead sponsor of 16 studies on the registry; 4 are open to participants now.
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(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
Inflow occlusion assisted by indocyanine green-fluorescence imaging combined with perforation of septation and sclerotherapy
Procedure: Inflow occlusion with perforation of septation and sclerotherapy
Perforation of septation and sclerotherapy
Procedure: Perforation of septation and sclerotherapy
Indocyanine green-fluorescence imaging-guided partial resection and sclerotherapy
Procedure: Indocyanine green-guided partial resection and sclerotherapy
Partial resection and sclerotherapy
Procedure: Partial resection and sclerotherapy
Inflow occlusion assisted by indocyanine green-fluorescence imaging combined with perforation of septation and sclerotherapy
Perforation of septation and sclerotherapy
Indocyanine green-fluorescence imaging-guided partial resection and sclerotherapy
Partial resection and sclerotherapy
Cure rate
The percentage of cured cases to total cases
Time frame: 1month, 3 months
Effective rate
The percentage of effective cases to total cases
Time frame: 1 month, 3 months
Treatment frequency
Frequency of treatments
Time frame: 3 months, 6 months
Likert score
Evaluation of postoperative satisfaction
Time frame: 6 months
Wound infection
Infection of surgical region
Time frame: 1 month
Delayed healing
Delayed healing of surgical wound
Time frame: 1 month
Pigmentation
ICG-related pigmentation on skin
Time frame: 1 month
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2023 (actual). Primary completion is estimated for Mar 2026, 38 months after the start.
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Nanjing Children's Hospital