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Clinical Trials in China / NCT06275022
Recruiting Not applicable

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

NCT06275022 · tracked via the Priya Life Science China tracker
Sponsor
Nanjing Children's Hospital
Phase
Not applicable
Started
2023-01-01
Last updated
2026-02-18

Condition(s) studied

Lymphatic Malformation

Investigational drug(s) / intervention(s)

Inflow occlusion with perforation of septation and sclerotherapyPerforation of septation and sclerotherapyIndocyanine green-guided partial resection and sclerotherapyPartial resection and sclerotherapy

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

Perforation of septation and sclerotherapy: Perforation of septation and sclerotherapy

Indocyanine green-guided partial resection and sclerotherapy: Indocyanine green-fluorescence imaging-guided partial resection and sclerotherapy

Partial resection and sclerotherapy: Partial resection and sclerotherapy

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

Sex
ALL
Min age
30 Days
Max age
16 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Cure rate — 1month, 3 months
    The percentage of cured cases to total cases
  • Effective rate — 1 month, 3 months
    The percentage of effective cases to total cases
  • Treatment frequency — 3 months, 6 months
    Frequency of treatments

Trial sites (1)

FacilityCityRegionStatus
Children's hospital of Nanjing medical university Nanjing Jiangsu Recruiting

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Other trials for the same condition

Use of Bleomycin in the Sclerotherapy of Lymphatic Malformations for Pediatric Patients Recruiting
Different Doses of Sirolimus for the Treatment of Cystic Lymphatic Malformations Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06275022 on ClinicalTrials.gov ↗ ← All trials in China