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NCT06160739

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

Status unknown Last updated 15 December 2023
What this trial tests

trial testing Sirolimus 1Mg Oral Tablet in Microcystic Lymphatic Malformation in 10 participants. Status unknown.

Timeline
20 November 2023
Primary endpoint
1 September 2024
1 September 2024

Quick facts

Lead sponsorSohag University
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment10
Start date20 November 2023
Primary completion1 September 2024
Estimated completion1 September 2024
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Sohag University

Who can join

Adults 6 Months to 12, any sex, with Microcystic Lymphatic Malformation or Combined Vascular Malformation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A Review of the Current State and Future Directions for Management of Scalp and Facial Vascular Malformations.
    Hartman E, Balkin DM, See AP. · · 2024 · cited 3× · PMID 38720545 · DOI 10.3340/jkns.2024.0032
  2. PI3K/AKT/mTOR axis in vascular malformations: from molecular insights to targeted clinical trials.
    Zheng YY, Hua C, Lin XX. · · 2025 · cited 1× · PMID 41430313 · DOI 10.1186/s13023-025-04115-2
  3. Targeted medical therapies for vascular anomalies.
    Borst A. · · 2024 · cited 1× · PMID 39644074 · DOI 10.1182/hematology.2024000599
  4. Vascular malformations: from genetics to therapeutics.
    Morin G, Galasso I, Canaud G. · · 2026 · PMID 41272322 · DOI 10.1038/s44321-025-00344-x

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Data sources for this page

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