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

Recruiting now · Phase 2

Conditions studied: Lymphatic Malformation

In brief

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.

Key facts

Study ID

NCT06437158

Run by

West China Hospital

People needed

200

Starts

2023-03-08

Expected to finish

2026-12-31

Last updated by the study team

2024-06-03

Who can join

Age: any, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• West China Hospital of Sichuan University — Chengdu, Sichuan, China (enrolling)

Full record on ClinicalTrials.gov

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