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Vascular Liver Diseases in Transgender Individuals Undergoing Gender-Affirming Hormone Therapy: A European Multicentre Observational Study

May 4, 2025

Background

Vascular liver diseases (VLD) such as porto-sinusoidal vascular disorder (PSVD), Budd-Chiari syndrome (BCS), and non-cirrhotic portal vein thrombosis (NCPVT) are rare but potentially severe conditions. While hormonal therapies are a known risk factor for VLD in cisgender individuals, data on transgender individuals undergoing gender-affirming hormone therapy (GAHT) remain anecdotal, mainly due to the rarity of these conditions. Unlike in cisgender patients, where hormonal therapy is often discontinued in the event of VLD, GAHT is typically maintained in transgender individuals, even after gender-affirming surgeries, as it is a core component of their transition process. The absence of systematic data limits clinical decision-making and may contribute to health disparities.

Study Design

  • Observational, retrospective and prospective study
  • European multicentre design, involving referral centres for vascular liver diseases, study population of transgender individuals who were receiving gender-affirming hormone therapy (GAHT) compared to control group, not receiving gender-affirming hormone therapy

Study Population

Inclusion Criteria

  • Confirmed diagnosis of a vascular liver disease (VLD) in transgender individuals who were receiving gender-affirming hormone therapy (GAHT) at the time of diagnosis and recorded in the French and European EN-Vie/Valdig cohort from centres willing to participate

Exclusion Criteria:

  • Advanced non-vascular liver diseases.
  • Non-continuous or undocumented hormone therapy.

For exploratory comparison purposes, each transgender patient receiving GAHT and diagnosed with VLD will be matched with three cisgender individuals with a comparable VLD subtype, based on age and sex assigned at birth.

Inclusion Criteria (Control Group):

  • Cisgender individuals with confirmed diagnosis of a VLD matched by subtype (PSVD, BCS, NCPVT) and recorded in the French and European EN-Vie/Valdig cohort from centres willing to participate

Exclusion Criteria (Control Group):

  • Advanced non-vascular liver diseases (e.g., viral cirrhosis, advanced MASLD)
  • Exposure to GAHT or any hormonal treatment

 

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Aims

Aims

Given the growing number of individuals accessing GAHT, this study aims to characterize, even exploratively, the clinical features, risk factors, and outcomes of VLD in transgender individuals, in order to support evidence-based and inclusive care strategies

Primary outcomes

Cumulative incidence of:

  • Liver-related mortality (LRM), defined as death due to liver failure, variceal bleeding, complications of portal hypertension.
  • Recurrent splanchnic vein thrombosis (e.g., portal, mesenteric, or splenic veins), occurring from the date of VLD diagnosis.

Secondary outcomes:

  • Proportion of transgender individuals with VLD occurring in the context of GAHT in the French and European EN-Vie/Valdig cohort.
  • Exploratory assessment of duration and type of GAHT with the development of VLD
  • Prevalence of congenital or acquired prothrombotic factors at diagnosis of VLD
  • Prevalence at diagnosis of VLD-related complications (Portal hypertension, Bowel ischemia, Organ failure).
  • Proportion of patients who discontinued or modified GAHT after the diagnosis of VLD.
  • Comparison of thrombotic recurrence and liver-related mortality between patients with VLD in GAHT and cisgender patients with comparable VLD

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