Journal of pediatric surgery · 2025
A randomised study examining the utility of lauromacrogol foam sclerotherapy vs pingyangmycin in treatment of pediatric lymphatic malformations --a single center report from China.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Song Dan, Wang Liang, Li Jing, Zhang Xin, Zhou Jie, Guo Lei
Аннотация
OBJECTIVE: To evaluate the efficacy and safety of ultrasound-guided percutaneous lauromacrogol foam sclerotherapy for lymphatic malformations in children.
METHODS: In this open-label randomized controlled trial, children with lymphatic malformations treated at the Children's Hospital Affiliated to Shandong University (Jinan Children's Hospital) between January 2022 and September 2023 were enrolled. Participants were randomly assigned using a random number table to receive either pingyangmycin or lauromacrogol foam sclerotherapy. All procedures were performed under ultrasound guidance. Cystic fluid was aspirated, and the sclerosant was injected after confirming a fluid-free dark area. Clinical efficacy, adverse events, and other outcomes were recorded and compared between groups.
RESULTS: A total of 238 children were enrolled: 126 in the pingyangmycin group and 112 in the lauromacrogol group. No significant differences in efficacy were observed between the two groups overall or across subtypes (macrocystic, mixed, or microcystic; all P > 0.05). However, the lauromacrogol group required fewer treatment sessions (1.35 ± 0.3 vs 2.19 ± 0.7, P < 0.05) and experienced fewer adverse events (12.5 % vs 38.9 %, P < 0.05) compared with the pingyangmycin group.
CONCLUSION: Ultrasound-guided lauromacrogol foam sclerotherapy is a safe and effective treatment for pediatric lymphatic malformations. Compared with pingyangmycin, it avoids the risks of antitumor drug toxicity, reduces the number of treatment sessions, and lowers adverse event incidence, offering greater clinical value in children.
METHODS: In this open-label randomized controlled trial, children with lymphatic malformations treated at the Children's Hospital Affiliated to Shandong University (Jinan Children's Hospital) between January 2022 and September 2023 were enrolled. Participants were randomly assigned using a random number table to receive either pingyangmycin or lauromacrogol foam sclerotherapy. All procedures were performed under ultrasound guidance. Cystic fluid was aspirated, and the sclerosant was injected after confirming a fluid-free dark area. Clinical efficacy, adverse events, and other outcomes were recorded and compared between groups.
RESULTS: A total of 238 children were enrolled: 126 in the pingyangmycin group and 112 in the lauromacrogol group. No significant differences in efficacy were observed between the two groups overall or across subtypes (macrocystic, mixed, or microcystic; all P > 0.05). However, the lauromacrogol group required fewer treatment sessions (1.35 ± 0.3 vs 2.19 ± 0.7, P < 0.05) and experienced fewer adverse events (12.5 % vs 38.9 %, P < 0.05) compared with the pingyangmycin group.
CONCLUSION: Ultrasound-guided lauromacrogol foam sclerotherapy is a safe and effective treatment for pediatric lymphatic malformations. Compared with pingyangmycin, it avoids the risks of antitumor drug toxicity, reduces the number of treatment sessions, and lowers adverse event incidence, offering greater clinical value in children.