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

Phase

N/A

Condition

Birth Defects

Holoprosencephaly

Treatment

Indocyanine green-guided partial resection and sclerotherapy

Perforation of septation and sclerotherapy

Inflow occlusion with perforation of septation and sclerotherapy

Clinical Study ID

NCT06275022

NanjingCH011665

Ages 30-16
All Genders

Study 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

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

Exclusion Criteria:

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

Study Design