Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas

Study Overview
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Brief Summary
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This study will attempt to determine how common liver hemangiomas are in children with infantile hemangiomas by comparing liver ultrasound results in patients with 1-4 cutaneous hemangiomas, 5 or more cutaneous hemangiomas, or at least 1 large hemangioma versus ultrasound results in children without hemangiomas. Other objectives of the study include identifying specific risk factors in patients who have liver hemangiomas and identifying risk factors in children with symptomatic liver hemangiomas.

Detailed Description
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Hemangioma of infancy is the most common tumor of childhood occurring in 4% to 10% of infants. While most hemangiomas are benign in behavior and involute spontaneously, some can cause significant morbidity due to their location and size. In addition, some hemangiomas may be associated with extracutaneous hemangiomas that result in significant morbidity. Certain high risk hemangiomas of infancy, specifically multiple cutaneous hemangiomas or a solitary large hemangioma, have been associated with hepatic hemangiomatosis; however, the exact number or size of the cutaneous lesions at which the risk increases and the protocol for evaluating these patients remain controversial. The true prevalence of hepatic hemangiomatosis is unknown since there have been no large scale prospective studies evaluating clinically asymptomatic patients with cutaneous hemangiomas for the presence of hepatic hemangiomatosis. One of the primary objectives of this study is to determine the incidence of hepatic hemangiomatosis in patients with hemangiomas of infancy by comparing hepatic ultrasound imaging results of patients with 1-4 cutaneous hemangiomas, 5 or more cutaneous hemangiomas, or at least 1 large hemangioma >30 cm2 versus imaging results in patients without cutaneous hemangiomas. The study will also attempt to identify specific risk factors associated with the development of hepatic hemangiomatosis and to identify associated risk factors in patients with clinically symptomatic hepatic hemangiomatosis.

Official Title
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Multiple Hemangiomas and Large Cutaneous Hemangiomas of Infancy: Incidence of Hepatic Hemangiomatosis

Conditions
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Hemangioma

Intervention / Treatment
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* Procedure: abdominal ultrasound
* Other: Dermatologic Examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants less than 6 months of age clinical diagnosis of 1-4 cutaneous hemangiomas clinical diagnosis of 5 or more cutaneous hemangiomas clinical diagnosis of at least 1 large cutaneous hemangioma greater than 30 cm2 Exclusion Criteria: Infants greater than 6 months of age

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: infants with cutaneous hemangiomas<br> | Procedure: abdominal ultrasound<br>* abdominal ultrasound to detect hepatic hemangiomas<br>Other: Dermatologic Examination<br>* Complete dermatologic examination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound | The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound | 2 years | 
| Presence of Hepatic Hemangiomas on Abdominal Ultrasound | The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk Factors Associated With the Development of Hepatic Hemangiomas | Which participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least 1 large cutaneous hemangioma) were found to have hepatic hemangiomas on abdominal ultrasound | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prospective cohort study