Actively Recruiting
A Prospective Randomized Controlled Study on the Treatment of Cystic Lymphatic Malformation Based on Indocyanine Green-fluorescence Imaging
Led by Nanjing Children's Hospital · Updated on 2026-02-18
110
Participants Needed
1
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore the role of indocyanine green-fluorescence imaging in diagnosing and treating cystic lymphatic malformation (cLM) in children. The study will compare this imaging approach with traditional surgical methods to provide clearer scientific evidence for future treatments and better understand the disease's development. Participants are divided into groups receiving different treatments, including inflow occlusion assisted by indocyanine green-fluorescence imaging combined with perforation of septation and sclerotherapy, perforation of septation and sclerotherapy alone, indocyanine green-guided partial resection and sclerotherapy, or partial resection and sclerotherapy. Those in the imaging groups receive special guidance during surgery using the indocyanine green method, while control groups receive traditional methods. During the study, researchers will evaluate cure rates and treatment effectiveness at one and three months after treatment, along with how often treatments are needed over six months. Secondary outcomes include wound infection, delayed healing, pigmentation, and patient scores six months post-treatment. Participants will be followed for three to six months to monitor results and side effects.
CONDITIONS
Brief Title
A Prospective Study on the Treatment of cLM Based on ICG Imaging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- No previous intervention for cystic lymphatic malformation
- Diagnosed with cystic lymphatic malformation by pretreatment MRI
- Willing to complete 3 to 6 months post-treatment follow-up
- Superficial cystic lymphatic malformation
You will not qualify if you...
- History of iodine allergy
- Syndromic cystic lymphatic malformation
- Severe liver or kidney dysfunction
- Intralesional hemorrhage
- Intralesional infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 months depending on treatment frequency
Participants receive one of several procedures involving indocyanine green-fluorescence imaging and sclerotherapy to treat cystic lymphatic malformation.
Visits occur as needed for treatment sessions and assessments over 3 to 6 months
Trial Site Locations
Total: 1 location
1
Children's hospital of Nanjing medical university
Nanjing, Jiangsu, China, 210008
Actively Recruiting
Research Team
T
Tao Han, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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