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Role of Sirolimus in Treatment of Microcystic , Mixed Lymphatic and Vascular Malformations

NCT06160739 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2023-12-15

No results posted yet for this study

Summary

Lympho-vascular malformations result from errors in embryologic vasculogenesis involving capillaries, veins, arteries, lymphatics, or a combination of these. Infantile haemangiomas \& Vascular malformations like : Capillary malformations \& Venous malformations : they increase in size and never regress on their own. \& They are generally present at birth, they enlarge in response to infection, hormonal changes or trauma . Lymphatic malformations can be classified into macrocystic (cyst diameter \>1cm), microcystic (cyst diameter \<1 cm), or mixed , in macrocystic lymphatic malformations, surgery and sclerotherapy are effective . Surgery of microcystic lymphatic malformations remains challenging due to their infiltrative nature \& Sclerotherapy is often impossible. As especially large microcystic and mixed malformations are still a therapeutic challenge, pharmaceutical treatment as sirolimus is used in last years as main line of treatment with great efficacy.

Conditions

  • Microcystic Lymphatic Malformation
  • Combined Vascular Malformation
  • Vascular Malformations

Interventions

DRUG

Sirolimus 1Mg Oral Tablet

patients with Microcystic , Mixed Lymphatic and Vascular Malformations will be given sirolimus 1 mg oral tab for 3-6 months with follow up of lesion size by clinical exam \& ultrasound \& MRI to compare lesion size before \& after use of the drug with observation of potential side effects \& after exclusion of it before use of the drug

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Eligibility

Min Age
6 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-20
Primary Completion
2024-09-01
Completion
2024-09-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06160739 on ClinicalTrials.gov