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临床试验/NCT03721783
NCT03721783招募中不适用

Infant and Child European Cryoablation Project ICECaP

Great Ormond Street Hospital for Children NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年6月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Occurrence and severity of complications arising from cryoablation treatment

研究概览

简要总结

A registry to audit the current range of applications, technical success rate, safety profile, complication rate and efficacy of cryoablation procedures being performed in children.

详细描述

Cryoablation involves image-guided insertion of single-use specialised needles or probes through the skin into a soft tissue or bone lesion. A mechanised unit is connected to the probe(s) and generates cyclical freezing and thawing of the tissues at the probe tip(s) via exchange of highly pressurised gases through the probe lumen(s), utilising the Joules-Thomson effect. Extreme freezing and thawing of the lesion causes permanent tissue destruction through both mechanical disruption of tissue membranes and a secondary immune response effect.

Cryoablation is one of several minimally invasive ablative techniques used to reduce the size of or to eradicate soft tissue and bone lesions. Ablative techniques are now an accepted standard of care for many benign and malignant lesions in adult practice. Cryoablation is widely used in the management of renal cell carcinoma, with medium-term outcomes matching surgical resection.

The advantages of cryoablation over surgery, particularly in a paediatric population, are:

  • Minimally invasive approach, therefore suitable for day case procedures and almost scarless
  • Significantly faster recovery times compared to complex surgical debulking
  • Minimal complication rates compared to surgery (less risk to nerves, blood vessels and critical solid organ)
  • Affords excellent pain relief (has an independent role in chronic pain management)

To date the use of cryoablation in children remains novel and under reported.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • all children in whom a clinical decision is made to treat with percutaneous cryoablation, to include those in whom cryoablation was not technically or clinically possible at any stage.

排除标准

  • 未提供

结局指标

主要结局

Occurrence and severity of complications arising from cryoablation treatment

时间窗: 2 years

Documentation and severity scoring of any complications arising from a cryoablation procedure, using the Society of Interventional Radiology (SIR) standards of practice committee classification of complications by outcome scoring system. The range of the outcome scoring system is A-F, with A being the least severe (no therapy, no consequence), and F being the most severe (resulting death). \[Omary et al. J Vasc Interv Radiol 2003; 14:S293-S295\]

次要结局

  • Change in maximal diameter of lesion following treatment(5 years)
  • Change in symptomatology following treatment(2 years)
  • Procedure failure(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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