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

ConditionLymphatic Malformation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-16
SponsorNanjing Children's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inflow occlusion with perforation of septation and sclerotherapy

    Procedure/Surgery

    Inflow occlusion assisted by indocyanine green-fluorescence imaging combined with perforation of septation and sclerotherapy

  • Perforation of septation and sclerotherapy

    Procedure/Surgery

    Perforation of septation and sclerotherapy

  • Indocyanine green-guided partial resection and sclerotherapy

    Procedure/Surgery

    Indocyanine green-fluorescence imaging-guided partial resection and sclerotherapy

  • Partial resection and sclerotherapy

    Procedure/Surgery

    Partial resection and sclerotherapy

Treatment groups

110 Participants
are divided into 4 treatment groups
Group A: Macro/mixed cystic lymphatic AExperimental treatment 1 intervention
Group B: Macro/mixed cystic lymphatic BActive comparator 1 intervention
Group C: Microcystic lymphatic AExperimental treatment 1 intervention
Group D: Microcystic lymphatic BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cure rate

The percentage of cured cases to total cases

Time frame
1month, 3 months
2

Effective rate

The percentage of effective cases to total cases

Time frame
1 month, 3 months
3

Treatment frequency

Frequency of treatments

Time frame
3 months, 6 months

Secondary outcomes

1

Likert score

Evaluation of postoperative satisfaction

Time frame
6 months
2

Wound infection

Infection of surgical region

Time frame
1 month
3

Delayed healing

Delayed healing of surgical wound

Time frame
1 month
4

Pigmentation

ICG-related pigmentation on skin

Time frame
1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanjing Children's Hospital

Lead sponsor

Source ClinicalTrials.gov
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