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

Last updated: December 24, 2024
Sponsor: Nanjing Children's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Birth Defects

Holoprosencephaly

Treatment

Inflow occlusion with perforation of septation and sclerotherapy

Perforation of septation and sclerotherapy

Partial resection 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

Total Participants: 110
Treatment Group(s): 4
Primary Treatment: Inflow occlusion with perforation of septation and sclerotherapy
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Children's hospital of Nanjing medical university

    Nanjing, Jiangsu 210008
    China

    Active - Recruiting

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