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
Conditions
Study Type
Enrollment (Estimated)
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
-
-
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
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)
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
|
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
|
Perforation of septation and sclerotherapy
|
|
Experimental: Microcystic lymphatic A
Indocyanine green-fluorescence imaging-guided partial resection and sclerotherapy
|
Indocyanine green-fluorescence imaging-guided partial resection and sclerotherapy
|
|
Active Comparator: Microcystic lymphatic B
Partial resection and sclerotherapy
|
Partial resection and sclerotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cure rate
Time Frame: 1month, 3 months
|
The percentage of cured cases to total cases
|
1month, 3 months
|
|
Effective rate
Time Frame: 1 month, 3 months
|
The percentage of effective cases to total cases
|
1 month, 3 months
|
|
Treatment frequency
Time Frame: 3 months, 6 months
|
Frequency of treatments
|
3 months, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Likert score
Time Frame: 6 months
|
Evaluation of postoperative satisfaction
|
6 months
|
|
Wound infection
Time Frame: 1 month
|
Infection of surgical region
|
1 month
|
|
Delayed healing
Time Frame: 1 month
|
Delayed healing of surgical wound
|
1 month
|
|
Pigmentation
Time Frame: 1 month
|
ICG-related pigmentation on skin
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Weimin Shen, Dr., Children's Hospital of Nanjing Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NanjingCH011665
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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