Use of Bleomycin in the Sclerotherapy of Lymphatic Malformations for Pediatric Patients
ConditionLymphatic Malformation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 14
SponsorWest China Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Bleomycin
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov