Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas

• Sponsor: Children's Mercy Hospital Kansas City (Other)
• Overall Status: Completed
• CT.gov ID: NCT00374335
• Collaborator: Medical College of Wisconsin (Other), University of California, San Francisco (Other), Columbia University (Other), Baylor College of Medicine (Other), Northwestern University (Other), St. Justine's Hospital (Other), Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
• Enrollment: 261
• Location: 1
• Arm: 1
• Duration (Months): 39
• Patients Per Site Per Month: 6.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hemangioma	Procedure: abdominal ultrasound; Other: Dermatologic Examination	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 261 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Multiple Hemangiomas and Large Cutaneous Hemangiomas of Infancy: Incidence of Hepatic Hemangiomatosis
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: infants with cutaneous hemangiomas	Procedure: abdominal ultrasound; abdominal ultrasound to detect hepatic hemangiomas; Other: Dermatologic Examination; Complete dermatologic examination

Outcome Measures

Primary Outcome Measures

1. Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound [2 years]

   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. Presence of Hepatic Hemangiomas on Abdominal Ultrasound [2 years]

   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

Secondary Outcome Measures

1. Risk Factors Associated With the Development of Hepatic Hemangiomas [2 years]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 6 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Mercy Hospital	Kansas City	Missouri	United States	64108

Sponsors and Collaborators

• Children's Mercy Hospital Kansas City
• Medical College of Wisconsin
• University of California, San Francisco
• Columbia University
• Baylor College of Medicine
• Northwestern University
• St. Justine's Hospital
• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Investigators

• Principal Investigator: Beth A Drolet, MD, Medical College of Wisconsin
• Principal Investigator: Maria Garzon, MD, Columbia University
• Principal Investigator: Kimberly A Horii, MD, Children's Mercy Hospital Kansas City
• Principal Investigator: Denise Metry, MD, Baylor College of Medicine
• Principal Investigator: Sarah Chamlin, MD, Northwestern University-Children's Memorial Hospital
• Principal Investigator: Ilona J Frieden, MD, University of California, San Francisco
• Principal Investigator: Julie Powell, MD, St. Justine's Hospital
• Principal Investigator: Anne Lucky, MD, Children's Hospital of Cincinnati
• Principal Investigator: Eulalia Baselga, MD, Hospital de la Santa Crue i Santa Pau

Study Documents (Full-Text)

None provided.

More Information

Publications

• Boon LM, Burrows PE, Paltiel HJ, Lund DP, Ezekowitz RA, Folkman J, Mulliken JB. Hepatic vascular anomalies in infancy: a twenty-seven-year experience. J Pediatr. 1996 Sep;129(3):346-54. Review.
• Bruckner AL, Frieden IJ. Hemangiomas of infancy. J Am Acad Dermatol. 2003 Apr;48(4):477-93; quiz 494-6. Review.
• Chiller KG, Passaro D, Frieden IJ. Hemangiomas of infancy: clinical characteristics, morphologic subtypes, and their relationship to race, ethnicity, and sex. Arch Dermatol. 2002 Dec;138(12):1567-76.
• Hughes JA, Hill V, Patel K, Syed S, Harper J, De Bruyn R. Cutaneous haemangioma: prevalence and sonographic characteristics of associated hepatic haemangioma. Clin Radiol. 2004 Mar;59(3):273-80.
• Metry DW, Hawrot A, Altman C, Frieden IJ. Association of solitary, segmental hemangiomas of the skin with visceral hemangiomatosis. Arch Dermatol. 2004 May;140(5):591-6. Review.

• Responsible Party: Children's Mercy Hospital Kansas City
• ClinicalTrials.gov Identifier: NCT00374335
• Other Study ID Numbers: 06 02 029E
• First Posted: Sep 11, 2006
• Last Update Posted: Sep 16, 2011
• Last Verified: Sep 1, 2011

• Keywords provided by Children's Mercy Hospital Kansas City: prospective cohort study
• Additional relevant MeSH terms: Hemangioma

Study Results

Participant Flow

Arm/Group Title	Group 1
Arm/Group Description	Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
Period Title: Overall Study
STARTED	261
COMPLETED	261
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Group 1
Arm/Group Description	Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
Overall Participants	261
Age (Count of Participants)
<=18 years	261 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	0.3 (0.1)
Sex: Female, Male (Count of Participants)
Female	192 73.6%
Male	69 26.4%
Region of Enrollment (participants) [Number]
United States	232 88.9%
Spain	13 5%
Canada	16 6.1%

Outcome Measures

1. Primary Outcome

Title	Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound
Description	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
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1
Arm/Group Description	Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
Measure Participants	261
Number [participants]	24 9.2%

2. Secondary Outcome

Title	Risk Factors Associated With the Development of Hepatic Hemangiomas
Description	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
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1
Arm/Group Description	Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
Measure Participants	261
Number [participants]	24 9.2%

3. Primary Outcome

Title	Presence of Hepatic Hemangiomas on Abdominal Ultrasound
Description	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
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Group 1
Arm/Group Description	Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
All Cause Mortality
	Group 1
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Group 1
	Affected / at Risk (%)	# Events
Total	0/261 (0%)
Other (Not Including Serious) Adverse Events
	Group 1
	Affected / at Risk (%)	# Events
Total	0/261 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.