Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas

Children's Mercy Hospital Kansas City

Status: Completed

Conditions: Hemangioma

Treatments: Other: Dermatologic Examination; Procedure: abdominal ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT00374335

06 02 029E

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 261 patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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261 participants in 1 patient group

infants with cutaneous hemangiomas

Other group

Treatment:

Procedure: abdominal ultrasound

Other: Dermatologic Examination