NCT Number: NCT07320001
This is a randomized clinical trial comparing the safety and effectiveness of injection sclerotherapy using bleomycin versus doxycycline in children under 12 years with lymphatic malformations. The study will assess reduction in lesion size, clinical improvement, and treatment-related complications over six months.
Trial opening soon.
Get Notified0 year–12 year
All sexes
Interventional
Phase 2
This randomized clinical trial aims to compare the effectiveness and safety of injection sclerotherapy using bleomycin versus doxycycline in pediatric patients under 12 years of age diagnosed with lymphatic malformations. Eligible participants will be randomly assigned to receive either bleomycin or doxycycline injections at Holy family hospital Rawalpindi Pakistan.
The study will monitor participants over a six-month follow-up period to assess primary outcomes, including reduction in lesion size and clinical improvement, as well as secondary outcomes such as treatment-related complications, number of treatment sessions required, and overall patient tolerance.
Standard hospital protocols for injection sclerotherapy will be followed, and safety will be monitored by the principal investigator and treating physicians. Participants' caregivers will provide informed consent prior to enrollment. This study is designed to provide evidence on the comparative effectiveness of bleomycin versus doxycycline for pediatric lymphatic malformations
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Age 0-12 years Radiological diagnosis of macrocytic/mixed lymphatic malformations. No prior sclerotherapy/surgical treatment. Informed consent from guardians
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Exclusion criteria
Injection sclerotherapy using bleomycin administered according to standard hospital protocol. The number of sessions and dosage are determined based on lesion size and patient response. Safety and adverse events are monitored by the principal investigator and treating physicians.
Injection sclerotherapy using doxycycline administered according to hospital protocol. The number of sessions and dosage are determined based on lesion size and patient response. Safety and adverse events are monitored by the principal investigator and treating physicians.
Time frame: 6 months.
Change in lymphatic malformation size measured as percentage reduction in lesion volume from baseline, assessed using ultrasonography (or MRI, if you are using MRI) at baseline and at 6 months after sclerotherapy.
Time frame: 6 months.
Number of participants who develop treatment-related complications, including pain, fever, infection, skin necrosis, swelling, or ulceration, assessed clinically and graded using CTCAE v5.0 (or v4.0) within 6 months after sclerotherapy.
Contact information is provided by the study sponsor or research team.
Basharat Hussain
Other
Injection Sclerotherapy With Bleomycin VS Doxycycline in Patients With Lymphatic Malformations:A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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