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Recruiting NCT06275022

A Prospective Study on the Treatment of cLM Based on ICG Imaging

Trial Parameters

Condition Lymphatic Malformation
Sponsor Nanjing Children's Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 110
Sex ALL
Min Age 30 Days
Max Age 16 Years
Start Date 2023-01-01
Completion 2026-03-20
Interventions
Inflow occlusion with perforation of septation and sclerotherapyPerforation of septation and sclerotherapyIndocyanine green-guided partial resection and sclerotherapy

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.

Eligibility Criteria

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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