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

Nanjing Children's Hospital

Status: Enrolling

Conditions: Lymphatic Malformation

Treatments: Procedure: Indocyanine green-guided partial resection and sclerotherapy; Procedure: Inflow occlusion with perforation of septation and sclerotherapy; Procedure: Perforation of septation and sclerotherapy; Procedure: Partial resection and sclerotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06275022

NanjingCH011665

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 30 days to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 4 patient groups

Macro/mixed cystic lymphatic A

Experimental group

Description:

Inflow occlusion assisted by indocyanine green-fluorescence imaging combined with perforation of septation and sclerotherapy

Treatment:

Procedure: Inflow occlusion with perforation of septation and sclerotherapy

Macro/mixed cystic lymphatic B

Active Comparator group

Description:

Perforation of septation and sclerotherapy

Treatment:

Procedure: Perforation of septation and sclerotherapy

Microcystic lymphatic A

Experimental group

Description:

Indocyanine green-fluorescence imaging-guided partial resection and sclerotherapy

Treatment:

Procedure: Indocyanine green-guided partial resection and sclerotherapy

Microcystic lymphatic B

Active Comparator group

Description:

Partial resection and sclerotherapy

Treatment:

Procedure: Partial resection and sclerotherapy