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Clinical Trials/NCT07616323
NCT07616323Not yet recruitingNot Applicable

Diameter Threshold for Screening LUMBAR Syndrome in Infants With Lumbosacral, Sacrococcygeal, Perineal, and Gluteal Infantile Hemangiomas: A Prospective Multicenter Cohort Study

West China Hospital1 site in 1 country70 target enrollmentStarted: June 1, 2026Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
70
Locations
1

Study Overview

Brief Summary

The objective of this study is to determine the maximal diameter threshold at which infants with lumbosacral, sacrococcygeal, perineal, gluteal, or lower-limb extending infantile hemangiomas should undergo screening for LUMBAR syndrome.

Detailed Description

Infantile hemangiomas located in the lumbosacral, sacrococcygeal, perineal, gluteal, or lower-limb-extending regions may be associated with LUMBAR syndrome. LUMBAR syndrome refers to a spectrum of regional congenital anomalies associated with lower-body infantile hemangiomas, including lower-body hemangioma, urogenital anomalies, ulceration, myelopathy or spinal dysraphism, bony deformities, anorectal malformations, arterial anomalies, and renal anomalies.

However, the optimal lesion size threshold for initiating systematic screening remains unclear. In current clinical practice, some patients with large or segmental hemangiomas undergo magnetic resonance imaging and systemic evaluation, whereas others with smaller but potentially high-risk lesions may not be screened. Therefore, a clinically practical and evidence-based diameter threshold is needed to guide LUMBAR syndrome screening.

Previous prospective evidence has suggested that lumbosacral infantile hemangiomas larger than 2.5 cm may be associated with a high rate of spinal anomalies. However, whether this 2.5-cm threshold applies to hemangiomas involving the sacrococcygeal, perineal, gluteal, or lower-limb-extending regions remains uncertain. Therefore, this study aims to prospectively evaluate the relationship between maximal lesion diameter and LUMBAR-associated anomalies and to identify an optimal screening threshold.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
0 Years to 10 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Clinically diagnosed infantile hemangioma.
  • Lesion located in at least one of the following regions: lumbosacral region, sacrococcygeal region, gluteal region, perineal region, perianal region, external genital region, or continuous extension to the lower limb.
  • Maximal lesion diameter ≥2.0 cm.
  • Written informed consent obtained from the parents or legal guardians.

Exclusion Criteria

  • Vascular anomaly other than infantile hemangioma, such as venous malformation, lymphatic malformation, arteriovenous malformation, or congenital hemangioma.
  • Previously diagnosed genetic or congenital syndrome unrelated to LUMBAR syndrome, which may independently explain the detected anomalies.
  • Incomplete clinical data preventing accurate measurement of lesion diameter.
  • Refusal of participation or refusal to complete core screening examinations.
  • Any condition judged by the investigators to be unsuitable for study participation.

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yi Ji

Clinical Professor

West China Hospital

Study Sites (1)

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