A Prospective Study on the Treatment of cLM Based on ICG Imaging
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Inflow occlusion with perforation of septation and sclerotherapy, Perforation of septation and sclerotherapy, Indocyanine green-guided partial resection and sclerotherapy, Partial resection and sclerotherapy.
- Who it may be relevant to
- Registry conditions: Lymphatic Malformation. Basic parameters: 30 Days — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Randomized Controlled Study on the Treatment of Cystic Lymphatic Malformation Based on Indocyanine Green-fluorescence Imaging
Overview
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.
Interventions
- Procedure Inflow occlusion with perforation of septation and sclerotherapy
Inflow occlusion assisted by indocyanine green-fluorescence imaging combined with perforation of septation and sclerotherapy - Procedure Perforation of septation and sclerotherapy
Perforation of septation and sclerotherapy - Procedure Indocyanine green-guided partial resection and sclerotherapy
Indocyanine green-fluorescence imaging-guided partial resection and sclerotherapy - Procedure Partial resection and sclerotherapy
Partial resection and sclerotherapy
Primary outcome measures
- Cure rate [Time frame: 1month, 3 months]
- Effective rate [Time frame: 1 month, 3 months]
- Treatment frequency [Time frame: 3 months, 6 months]
Secondary outcome measures (4)
- Likert score [Time frame: 6 months]
- Wound infection [Time frame: 1 month]
- Delayed healing [Time frame: 1 month]
- Pigmentation [Time frame: 1 month]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Children's hospital of Nanjing medical university — Nanjing
Identifiers
NCT: NCT06275022 · NanjingCH011665