RecruitingPhase 2NCT06437158

Use of Bleomycin in the Sclerotherapy of Lymphatic Malformations for Pediatric Patients

Efficacy and Safety of Different Concentrations of Bleomycin in the Sclerotherapy of Lymphatic Malformations for Pediatric Patients


Sponsor

West China Hospital

Enrollment

200 participants

Start Date

Mar 8, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Bleomycin has nowadays been more and more widely used in the sclerotherapy of LMs, which has been proven to be primarily dose dependent. The investigators aim to compare the efficacy and safety of different concentrations of Bleomycin in the sclerotherapy of LMs for pediatric patients.


Eligibility

Max Age: 14 Years

Inclusion Criteria3

  • Male or female participants less than 14 years of age at the time of informed consent/assent form was signed.
  • Participants whose parents have voluntarily given written consent and participants who provided assent (if applicable) after the study has been explained to them.
  • Participants with LMs of all sites measured and confirmed via imaging at screening, with rapid progression, resluting in obvious symptoms or dysfunction, which could not be radically resected and could be treated by sclerotherapy.

Exclusion Criteria4

  • Penicillin allergy.
  • Vascular tumors or combined vascular malformations.
  • Participants who may have had surgical or sclerotherapy treatment by other hardeners.
  • LMs growing slowly, without obvious symptoms or dysfunction, which does not need to be treated prematurely.

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Interventions

DRUGBleomycin

To validated the efficacy and safety of different concentrations of Bleomycin in the sclerotherapy of lymphatic malformations for pediatric patients


Locations(1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

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NCT06437158


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