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

Not Applicable

Recruiting

• Conditions: Lymphatic Malformation
• Interventions: Procedure: Partial resection and sclerotherapy; Procedure: Inflow occlusion with perforation of septation and sclerotherapy; Procedure: Perforation of septation and sclerotherapy; Procedure: Indocyanine green-guided partial resection and sclerotherapy

• Registration Number: NCT06275022
• Lead Sponsor: Nanjing Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2024-02-16
• Study First Submitted QC: 2024-02-16
• Study First Posted: 2024-02-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microcystic lymphatic B	Partial resection and sclerotherapy	Partial resection and sclerotherapy
Macro/mixed cystic lymphatic A	Inflow occlusion with perforation of septation and sclerotherapy	Inflow occlusion assisted by indocyanine green-fluorescence imaging combined with perforation of septation and sclerotherapy
Macro/mixed cystic lymphatic B	Perforation of septation and sclerotherapy	Perforation of septation and sclerotherapy
Microcystic lymphatic A	Indocyanine green-guided partial resection and sclerotherapy	Indocyanine green-fluorescence imaging-guided partial resection and sclerotherapy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Likert score	6 months	Evaluation of postoperative satisfaction
Wound infection	1 month	Infection of surgical region
Pigmentation	1 month	ICG-related pigmentation on skin
Delayed healing	1 month	Delayed healing of surgical wound

Trial Locations

Locations (1)

Children's hospital of Nanjing medical university; 🇨🇳 Nanjing, Jiangsu, China