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临床试验/NCT07616323
NCT07616323尚未招募不适用

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

West China Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
0 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yi Ji

Clinical Professor

West China Hospital

研究点 (1)

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