RecruitingNot ApplicableNCT06275022

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

A Prospective Randomized Controlled Study on the Treatment of Cystic Lymphatic Malformation Based on Indocyanine Green-fluorescence Imaging


Sponsor

Nanjing Children's Hospital

Enrollment

110 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 30 DaysMax Age: 16 Years

Inclusion Criteria1

  • (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 Criteria1

  • (1) history of iodine allergy; (2) syndromic cLM ; (3) severe liver and kidney dysfunction; (4) intralesional hemorrhage; (5) intralesional infection

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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


Locations(1)

Children's hospital of Nanjing medical university

Nanjing, Jiangsu, China

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NCT06275022


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