Lymphatic MalformationNCT06275022
A Prospective Study on the Treatment of cLM Based on ICG Imaging
A study testing Inflow occlusion with perforation of septation and sclerotherapy, Perforation of septation and sclerotherapy and Indocyanine green-guided partial resection and sclerotherapy in people with Lymphatic Malformation, run by Nanjing Children's Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 30 days to 16 years
- Conditions the study is for
- Lymphatic Malformation
- What is being tested?
- Inflow occlusion with perforation of septation and sclerotherapy, Perforation of septation and sclerotherapy and Indocyanine green-guided partial resection and sclerotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 days to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- no previous intervention; (2) cLM diagnosed by pretreatment magnetic resonance imaging (MRI); (3)3 to 6 months post-treatment follow-up; (4) Superfacial cLM
Who cannot join
- history of iodine allergy; (2) syndromic cLM ; (3) severe liver and kidney dysfunction; (4) intralesional hemorrhage; (5) intralesional infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's hospital of Nanjing medical university
Nanjing, Jiangsu, 210008
Tao Han, Dr., +86 186 5190 3495, dr.hantao@njmu.edu.cn
About this study
Official title: 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.
- Conditions
- Lymphatic Malformation
- Being tested
- Inflow occlusion with perforation of septation and sclerotherapy, Perforation of septation and sclerotherapy, Indocyanine green-guided partial resection and sclerotherapy, Partial resection and sclerotherapy
- Keywords
- indocyanine green, children, inflow, lymphography
- Medical subject headings
- Lymphatic Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inflow occlusion with perforation of septation and sclerotherapyProcedure or surgery
Inflow occlusion assisted by indocyanine green-fluorescence imaging combined with perforation of septation and sclerotherapy
Perforation of septation and sclerotherapyProcedure or surgery
Perforation of septation and sclerotherapy
Indocyanine green-guided partial resection and sclerotherapyProcedure or surgery
Indocyanine green-fluorescence imaging-guided partial resection and sclerotherapy
Partial resection and sclerotherapyProcedure or surgery
Partial resection and sclerotherapy
| Study group | Role | What they receive |
|---|---|---|
| Macro/mixed cystic lymphatic A | Experimental | Inflow occlusion assisted by indocyanine green-fluorescence imaging combined with perforation of septation and sclerotherapy Receives: Procedure: Inflow occlusion with perforation of septation and sclerotherapy |
| Macro/mixed cystic lymphatic B | Active comparator | Perforation of septation and sclerotherapy Receives: Procedure: Perforation of septation and sclerotherapy |
| Microcystic lymphatic A | Experimental | Indocyanine green-fluorescence imaging-guided partial resection and sclerotherapy Receives: Procedure: Indocyanine green-guided partial resection and sclerotherapy |
| Microcystic lymphatic B | Active comparator | Partial resection and sclerotherapy Receives: Procedure: Partial resection and sclerotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate
The percentage of cured cases to total cases
Measured: 1month, 3 months
Effective rate
The percentage of effective cases to total cases
Measured: 1 month, 3 months
Treatment frequency
Frequency of treatments
Measured: 3 months, 6 months
Secondary outcomes (4)
Likert score
Evaluation of postoperative satisfaction
Measured: 6 months
Wound infection
Infection of surgical region
Measured: 1 month
Delayed healing
Delayed healing of surgical wound
Measured: 1 month
Pigmentation
ICG-related pigmentation on skin
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 Jan 2023
- Primary completion20 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphatic MalformationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Han, Nanjing Children's Hospital
- Investigators
- Weimin Shen, Dr., Study director, Children's Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275022
- Sponsor's protocol ID
- NanjingCH011665
- Status last verified
- May 2025
- First submitted
- 16 Feb 2024
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study on the Treatment of Cystic Lymphatic Malformation Based on Indocyanine Green-fluorescence Imaging
- ClinicalTrials.gov ID
- NCT06275022
- Acronym / sponsor ID
- NanjingCH011665
- Conditions
- Lymphatic Malformation
- Keywords
- indocyanine green, children, inflow, lymphography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Nanjing Children's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Macro/mixed cystic lymphatic A | Experimental | Procedure: Inflow occlusion with perforation of septation and sclerotherapyInflow occlusion assisted by indocyanine green-fluorescence imaging combined with perforation of septation and sclerotherapy |
| Macro/mixed cystic lymphatic B | Active comparator | Procedure: Perforation of septation and sclerotherapyPerforation of septation and sclerotherapy |
| Microcystic lymphatic A | Experimental | Procedure: Indocyanine green-guided partial resection and sclerotherapyIndocyanine green-fluorescence imaging-guided partial resection and sclerotherapy |
| Microcystic lymphatic B | Active comparator | Procedure: Partial resection and sclerotherapyPartial resection and sclerotherapy |
Who may qualify
- Ages
- 30 days to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- no previous intervention; (2) cLM diagnosed by pretreatment magnetic resonance imaging (MRI); (3)3 to 6 months post-treatment follow-up; (4) Superfacial cLM
Key exclusion criteria (1 listed)
- history of iodine allergy; (2) syndromic cLM ; (3) severe liver and kidney dysfunction; (4) intralesional hemorrhage; (5) intralesional infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inflow occlusion with perforation of septation and sclerotherapyInflow occlusion assisted by indocyanine green-fluorescence imaging combined with perforation of septation and sclerotherapy | Procedure or surgery | Macro/mixed cystic lymphatic A |
| Perforation of septation and sclerotherapyPerforation of septation and sclerotherapy | Procedure or surgery | Macro/mixed cystic lymphatic B |
| Indocyanine green-guided partial resection and sclerotherapyIndocyanine green-fluorescence imaging-guided partial resection and sclerotherapy | Procedure or surgery | Microcystic lymphatic A |
| Partial resection and sclerotherapyPartial resection and sclerotherapy | Procedure or surgery | Microcystic lymphatic B |
Primary outcome
Cure rate
Time frame: 1month, 3 months
The percentage of cured cases to total cases
Effective rate
Time frame: 1 month, 3 months
The percentage of effective cases to total cases
Treatment frequency
Time frame: 3 months, 6 months
Frequency of treatments
4 secondary outcomes
Likert score
Time frame: 6 months
Wound infection
Time frame: 1 month
Delayed healing
Time frame: 1 month
Pigmentation
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Weimin Shen, Dr. study director
Children's Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inflow occlusion with perforation of septation and sclerotherapy, Perforation of septation and sclerotherapy and Indocyanine green-guided partial resection and sclerotherapy in people with Lymphatic Malformation, run by Nanjing Children's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tao Han, Dr. (+86 186 5190 3495, dr.hantao@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate (time frame: 1month, 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.