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临床试验/NCT03153332
NCT03153332已完成不适用

Value of 3D Printing for Comprehension of Liver Surgical Anatomy

Guangzhou Women and Children's Medical Center1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
59
试验地点
1
主要终点
The primary outcomes was the precise allocation of hepatic disease

研究概览

简要总结

To our knowledge, it has not been analyze whether 3D printed liver model would improve the perception of a given liver tumor or the precision of operation planning in liver surgery. We design this prospective controlled trial to test whether the 3D-printed patient specific liver model could be more informative than standard MDCT (multi-row detector computed tomography ) and 3D visualization system in predicting the surgical anatomy of liver.

详细描述

The primary objective was to investigate whether 3D printing can improve localization of hepatic pathology. The secondary objective was to investigate whether 3D printing can improve the precision of surgical proposal.

The dataset of patients were prepared and stratified into MDCT, 3D visualization system and 3D printed liver model groups. The process started from MDCT scan image acquisition and moved through image segmentation and 3D rendering to end up with 3D printing.

Surgical residents were assigned to three different groups to study different modes of patients' data. Residents were ask to state the liver segment in which the tumor resides and make a minimal resection proposal, including the tumor, the safety margin (1cm) and the dependent liver tissue. Residents were recommended to proceed in a classic way by resecting the whole liver segment. The time spent by each resident was also recorded in order to assess the quickness of comprehension and information transfer of the three different modes of presentation.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Surgical residents
  • Must had experiences with MDCT and 3D visualization system

排除标准

  • Non surgical residents
  • No experiences with MDCT or 3D visualization system

结局指标

主要结局

The primary outcomes was the precise allocation of hepatic disease

时间窗: The primary outcome was assessed within 1 week after the collection of each participants' response.

For tumor allocation to the liver segments, 8 points were awarded if all segments were correctly identified in which the tumors resided. If the tumors was located in more than one segment, the 8 maximal achievable points were divided between these segments. Erroneously identified segments were awarded 0 point. Alternatively, the primary outcomes were also simply judged as right or wrong according to the final surgical results.

次要结局

  • Resection proposal of liver pathology(The secondary outcome was assessed within 1 week after the collection of each participants' response.)
  • Time spent to judge tumor location(The secondary outcome was assessed within 1 week after the collection of each participants' response.)

研究者

发起方
Guangzhou Women and Children's Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tianyou Yang

Principal Investigator

Guangzhou Women and Children's Medical Center

研究点 (1)

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