NCT06275022

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Nanjing Children's Hospital · Academic / Other
• Sex: All
• Age: 30 Days – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphatic Malformation

Interventions

Type	Name	Description
PROCEDURE	Inflow occlusion with perforation of septation and sclerotherapy	Inflow occlusion assisted by indocyanine green-fluorescence imaging combined with perforation of septation and sclerotherapy
PROCEDURE	Perforation of septation and sclerotherapy	Perforation of septation and sclerotherapy
PROCEDURE	Indocyanine green-guided partial resection and sclerotherapy	Indocyanine green-fluorescence imaging-guided partial resection and sclerotherapy
PROCEDURE	Partial resection and sclerotherapy	Partial resection and sclerotherapy

Timeline

• Start date: 2023-01-01
• Primary completion: 2026-03-20
• Completion: 2026-03-30
• First posted: 2024-02-23
• Last updated: 2026-02-18

Locations

1 site across 1 country: China