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临床试验/NCT07155616
NCT07155616Enrolling By Invitation不适用

Computational Tool for Measuring Arterial Flow From CT

Hospital Clinic of Barcelona1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
100
试验地点
1
主要终点
Accuracy of blood flow modification prediction

研究概览

简要总结

Major invasive surgery, such as oncological abdominal surgery, is associated with a high risk of complications and mortality.

One of the main problems in this type of surgery is the difficulty in preserving the arteries and veins necessary to support vital organs.

The main objective of this project is to develop software to predict vascular flow changes based on preoperative computed tomography (CT) scans.

Currently, the only way to assess preoperative vascular flow is through percutaneous angiography. This is an invasive procedure that requires anaesthesia, hospitalisation, high doses of radiation, vessel manipulation and the possibility of serious injury. It is often used for the diagnosis of vascular stenosis, analysis of vascular flow and preoperative planning to determine which vessels are directly related to organ perfusion.

This preoperative planning will be key in the following clinical scenarios:

  1. Anomalous hepatic artery anatomy in pancreaticoduodenectomy.
  2. Celiac trunk stenosis.
  3. Hepatic artery revascularisation from the superior mesenteric artery.
  4. Hepatic artery flow assessment in liver transplantation.
  5. Splenic artery flow steal phenomenon in liver transplantation.

Novella aims to develop a tool that has the capability to predict postoperative vascular flow.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Candidates for pancreaticoduodenectomy.
  • Good quality preoperative DICOM CT (arterial phase).
  • Michel's I arterial configuration.
  • Any surgical approach (open or robotic).
  • Informed consent.

排除标准

  • Age < 18 years.
  • Technical inability to measure flow.
  • GDA infiltration.

结局指标

主要结局

Accuracy of blood flow modification prediction

时间窗: 10 months

Compare software's blood flow modification prediction with introperative measurement in each patient.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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