A Prospective Randomized Controlled Study on the Treatment of Cystic Lymphatic Malformation Based on Indocyanine Green-fluorescence Imaging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Treatment frequency
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Days 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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
排除标准
- •(1) history of iodine allergy; (2) syndromic cLM ; (3) severe liver and kidney dysfunction; (4) intralesional hemorrhage; (5) intralesional infection
研究组 & 干预措施
Macro/mixed cystic lymphatic A
Inflow occlusion assisted by indocyanine green-fluorescence imaging combined with perforation of septation and sclerotherapy
干预措施: Inflow occlusion with perforation of septation and sclerotherapy (Procedure)
Macro/mixed cystic lymphatic B
Perforation of septation and sclerotherapy
干预措施: Perforation of septation and sclerotherapy (Procedure)
Microcystic lymphatic A
Indocyanine green-fluorescence imaging-guided partial resection and sclerotherapy
干预措施: Indocyanine green-guided partial resection and sclerotherapy (Procedure)
Microcystic lymphatic B
Partial resection and sclerotherapy
干预措施: Partial resection and sclerotherapy (Procedure)
结局指标
主要结局
Treatment frequency
时间窗: 3 months, 6 months
Frequency of treatments
Cure rate
时间窗: 1month, 3 months
The percentage of cured cases to total cases
Effective rate
时间窗: 1 month, 3 months
The percentage of effective cases to total cases
次要结局
- Likert score(6 months)
- Wound infection(1 month)
- Pigmentation(1 month)
- Delayed healing(1 month)
研究者
Tao Han
Dr.
Nanjing Children's Hospital