Lymphatic Abnormality
Conditions
Brief summary
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.
Detailed description
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
Interventions
DRUGBleomycin
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.
Sponsors
Basharat Hussain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
Age 0-12 years Radiological diagnosis of macrocytic/mixed lymphatic malformations. No prior sclerotherapy/surgical treatment. Informed consent from guardians \-
Exclusion criteria
* microcytic lymphatic malformations Allergies to bleomycin/Doxycycline. Significant co morbidities Active infection at lesion site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in lymphatic malformation volume from baseline at 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related complications within 6 months | 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. |
Contacts
Primary ContactBasharat Hussain
Outcome results
None listed