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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Bleomycin
DrugTo validated the efficacy and safety of different concentrations of Bleomycin in the sclerotherapy of lymphatic malformations for pediatric patients
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Low-dose Concentrations (1mg/ml) of BleomycinExperimental treatment 1 intervention
Group B: High-dose Concentrations (2mg/ml) of BleomycinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes of Volume
Changes of Volume is defined as follows: a complete (90%-100% reduction in LMs volume), substantial (60%-89% reduction in LMs volume), intermediate (20%-59% reduction in LMs volume), or no (\< 20% reduction in LMs volume) response 3 to 6 months post-therapy as assessed by imaging.
Time frame
3 to 6 months post-therapySecondary outcomes
1
Score of Pain
Score of Pain is selfassessed at each visit on a 0 to 10 visual analog scale (where 0 indicates no pain and 10 indicates the worst pain imaginable), reported along with period duration.
Time frame
3 to 6 months post-therapy2
Global Efficacy
Global efficacy is assessed at each visit beginning at MS by the physician and self-assessed by the participant and proxy (parents) on a 0 to 10 visual analog scale (where 0 indicates no efficacy and 10 indicates complete resolution).
Time frame
3 to 6 months post-therapy3
Score of Quality of Life
Score of Quality of Life is assessed by the validated Children-Dermatological Life Quality Index (C-DLQI).
Time frame
3 to 6 months post-therapy4
Number of Participants with Efficacy
Number of Participants with Efficacy was assessed by 2 independent experts.
Time frame
3 to 6 months post-therapySponsors and contacts
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Source ClinicalTrials.gov