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

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

Study Overview

• Status: Recruiting
• Conditions: Lymphatic Malformation
• Intervention / Treatment: Procedure: Inflow occlusion with perforation of septation and sclerotherapy; Procedure: Perforation of septation and sclerotherapy; Procedure: Indocyanine green-guided partial resection and sclerotherapy; Procedure: Partial resection and sclerotherapy

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tao Han, Dr.; Phone Number: +86 186 5190 3495; Email: dr.hantao@njmu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Children's Hospital of Nanjing Medical University
      • Contact: Tao Han, Dr.; Phone Number: +86 186 5190 3495; Email: dr.hantao@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Macro/mixed cystic lymphatic A; Inflow occlusion assisted by indocyanine green-fluorescence imaging combined with perforation of septation and sclerotherapy	Procedure: Inflow occlusion with perforation of septation and sclerotherapy; Inflow occlusion assisted by indocyanine green-fluorescence imaging combined with perforation of septation and sclerotherapy
Active Comparator: Macro/mixed cystic lymphatic B; Perforation of septation and sclerotherapy	Procedure: Perforation of septation and sclerotherapy; Perforation of septation and sclerotherapy
Experimental: Microcystic lymphatic A; Indocyanine green-fluorescence imaging-guided partial resection and sclerotherapy	Procedure: Indocyanine green-guided partial resection and sclerotherapy; Indocyanine green-fluorescence imaging-guided partial resection and sclerotherapy
Active Comparator: Microcystic lymphatic B; Partial resection and sclerotherapy	Procedure: Partial resection and sclerotherapy; Partial resection and sclerotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nanjing Children's Hospital
• Investigators: Study Director: Weimin Shen, Dr., Children's Hospital of Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): March 20, 2026
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 15, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: children; indocyanine green; inflow; lymphography
• Additional Relevant MeSH Terms: Lymphatic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; Lymphatic Abnormalities; Therapeutics; Drug Therapy; Sclerotherapy
• Other Study ID Numbers: NanjingCH011665

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No