Injection Sclerotherapy With Bleomycin VS Doxycycline in Patients With Lymphatic Malformations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-26

Study Completion Date

2026-09-26

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Lymphatic Abnormality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bleomycin sclerotherapy

Group Type ACTIVE_COMPARATOR

Bleomycin

Intervention Type DRUG

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.

Doxycycline sclerotherapy

Group Type EXPERIMENTAL

doxycycline (tetracycline)

Intervention Type DRUG

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.

Interventions

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Bleomycin

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.

Intervention Type DRUG

doxycycline (tetracycline)

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.

Intervention Type DRUG

Eligibility Criteria

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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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