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NCT Number: NCT06275022

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

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.

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Key information

Conditions

Lymphatic Malformation Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hemic and Lymphatic Diseases Lymphatic Abnormalities Lymphatic Diseases

Age range

30 day–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's hospital of Nanjing medical university

Nanjing, Jiangsu, 210008, China

Location status: Recruiting

Location contact

Tao Han, Dr.

CONTACT

[email protected]

+86 186 5190 3495

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inflow occlusion with perforation of septation and sclerotherapy

Procedure

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

Perforation of septation and sclerotherapy

Procedure

Perforation of septation and sclerotherapy

Indocyanine green-guided partial resection and sclerotherapy

Procedure

Indocyanine green-fluorescence imaging-guided partial resection and sclerotherapy

Partial resection and sclerotherapy

Procedure

Partial resection and sclerotherapy

Primary outcomes

  1. Cure rate

    Time frame: 1month, 3 months

    The percentage of cured cases to total cases

  2. Effective rate

    Time frame: 1 month, 3 months

    The percentage of effective cases to total cases

  3. Treatment frequency

    Time frame: 3 months, 6 months

    Frequency of treatments

Secondary outcomes

  1. Likert score

    Time frame: 6 months

    Evaluation of postoperative satisfaction

  2. Wound infection

    Time frame: 1 month

    Infection of surgical region

  3. Delayed healing

    Time frame: 1 month

    Delayed healing of surgical wound

  4. Pigmentation

    Time frame: 1 month

    ICG-related pigmentation on skin

Study contacts

Contact information is provided by the study sponsor or research team.

Tao Han, Dr.

CONTACT

[email protected]

+86 186 5190 3495

Sponsors and collaborators

Lead sponsor

Nanjing Children's Hospital

Other

Registry information

Official study title

A Prospective Randomized Controlled Study on the Treatment of Cystic Lymphatic Malformation Based on Indocyanine Green-fluorescence Imaging

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2024
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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