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

NCT06275022 | Recruiting

• 1 other identifier: NanjingCH011665
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

indocyanine green; children; inflow; lymphography

Outcome Measures

Primary Outcomes (3)

• Cure rate

  The percentage of cured cases to total cases

  1month, 3 months

• Effective rate

  The percentage of effective cases to total cases

  1 month, 3 months

• Treatment frequency

  Frequency of treatments

  3 months, 6 months

Secondary Outcomes (4)

• Likert score

  6 months

• Wound infection

  1 month

• Delayed healing

  1 month

• Pigmentation

  1 month

Study Arms (4)

Macro/mixed cystic lymphatic A

EXPERIMENTAL

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

Procedure: Inflow occlusion with perforation of septation and sclerotherapy

Macro/mixed cystic lymphatic B

ACTIVE COMPARATOR

Perforation of septation and sclerotherapy

Procedure: Perforation of septation and sclerotherapy

Microcystic lymphatic A

EXPERIMENTAL

Indocyanine green-fluorescence imaging-guided partial resection and sclerotherapy

Procedure: Indocyanine green-guided partial resection and sclerotherapy

Microcystic lymphatic B

ACTIVE COMPARATOR

Partial resection and sclerotherapy

Procedure: Partial resection and sclerotherapy

Interventions

Inflow occlusion with perforation of septation and sclerotherapy PROCEDURE

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

Macro/mixed cystic lymphatic A

Perforation of septation and sclerotherapy PROCEDURE

Perforation of septation and sclerotherapy

Macro/mixed cystic lymphatic B

Indocyanine green-guided partial resection and sclerotherapy PROCEDURE

Indocyanine green-fluorescence imaging-guided partial resection and sclerotherapy

Microcystic lymphatic A

Partial resection and sclerotherapy PROCEDURE

Partial resection and sclerotherapy

Microcystic lymphatic B

Eligibility Criteria

• Age: 30 Days - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• (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

You may not qualify if:

• (1) history of iodine allergy; (2) syndromic cLM ; (3) severe liver and kidney dysfunction; (4) intralesional hemorrhage; (5) intralesional infection

Sponsors & Collaborators

• Nanjing Children's Hospital: lead

Study Sites (1)

Children's hospital of Nanjing medical university

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Lymphatic Abnormalities

Interventions

Sclerotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Weimin Shen, Dr.

  Children's Hospital of Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Tao Han, Dr.

CONTACT

+86 186 5190 3495; dr.hantao@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: February 23, 2024
• Study Start: January 1, 2023
• Primary Completion: March 20, 2026
• Study Completion: March 30, 2026
• Last Updated: February 18, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)