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

Lymphatic Malformation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06275022
• Other study ID #: NanjingCH011665
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: February 2024
• Source: Nanjing Children's Hospital
• Contact: Tao Han, Dr.
• Phone: +86 186 5190 3495
• Email: dr.hantao[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Days to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Lymphangioma
• Lymphatic Abnormalities
• Lymphatic Malformation

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
China	Children's hospital of Nanjing medical university	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure rate	The percentage of cured cases to total cases	1month, 3 months
Primary	Effective rate	The percentage of effective cases to total cases	1 month, 3 months
Primary	Treatment frequency	Frequency of treatments	3 months, 6 months
Secondary	Likert score	Evaluation of postoperative satisfaction	6 months
Secondary	Wound infection	Infection of surgical region	1 month
Secondary	Delayed healing	Delayed healing of surgical wound	1 month
Secondary	Pigmentation	ICG-related pigmentation on skin	1 month