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临床试验/NCT05304572
NCT05304572已完成不适用

Interobserver Agreement of Determination of Hepatocellular Carcinoma Feeding Vessels : Multi-Detector CT Angiography With 3D Reconstruction Versus Digital Subtraction Angiography

Assiut University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
feeding vessels detectability

研究概览

简要总结

This study aims to investigate the feasibility and accuracy of Multi-Detector CT angiography acquired before Trans-arterial Chemo-embolization (TACE) in detecting Hepato-cellular carcinoma feeding vessels compared to DSA angiography acquired during TACE.

详细描述

Hepatocellular carcinoma (HCC) represents the sixth most common cancer worldwide. Trans-arterial chemoembolization (TACE) is a palliative treatment for patients with HCC who are not candidates for transplantation, surgical resection, or loco-regional ablation. This minimally invasive procedure allows delivery of a high concentration of particles and/or chemotherapeutic agents into the liver, causing ischemic cell death and permitting local delivery of high concentrations of chemotherapeutic drug. Selective administration of chemo-embolic material to the tumor is desired, where possible, to increase the effectiveness of treatment to the tumor and minimize injury to surrounding liver tissue.

Tumor detection and assessment of the tumor-feeding vessel(s) are important for an effective treatment, while limiting non-target embolization. Usually, selection of the tumor-feeding vessels during TACE has been guided by 2D digital subtraction angiography (DSA). However; this method has a disadvantage of occasional misinterpretation of tumor-feeding vessels due to superimposition of vessels. To prevent such misinterpretation, multiple selective injections and oblique projections are performed during TACE with consequent increase in procedure time, volume of injected contrast material, and radiation doses.

A relatively new approach using three-dimensional (3D) cone-beam CT angiography during TACE is reported to be extremely helpful, especially in cases of complex hepatic arterial anatomy. However, the time required for processing and evaluating this 3D angiography images may discourage its routine use by intervention radiologists because it requires either a sterile remote control for in-room review or the operator exit from the angiographic room to access a workstation. A new automatic specifically designed softwares has been developed for detection of feeding vessels after Cone beam CT, but these softwares are not widely available.

Multiphasic contrast enhanced CT is one of the recommended imaging tools for diagnosis of HCC and is routinely done before TACE. There are few reports on the application of Multi-Detector CT angiography for detection of HCC feeding vessels before TACE.

This study aims to investigate the feasibility and accuracy of Multi-Detector CT angiography for assessment of tumor-feeding vessel in patients planned for TACE compared to DSA angiography acquired during TACE.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with HCC not suitable for resection, liver transplantation, or percutaneous ablation.
  • CHILD class A/B cirrhosis.
  • patent main portal vein.
  • less than 50% involvement of the liver by the tumor.
  • no vascular invasion or extrahepatic spread of the HCC.
  • normal renal functions.
  • bilirubin level < 2 mg/dl .

排除标准

  • Pre-TACE Multi-Detector CT raw DICOM images could not be obtained for 3D processing
  • patients with only available Pre-TACE MRI images
  • Failed TACE due to technical factors
  • Non-selective TACE technique

结局指标

主要结局

feeding vessels detectability

时间窗: Baseline

The observers will evaluate DSA images of the celiac, superior mesenteric artery (SMA), common hepatic artery (CHA), right or left hepatic arteries obtained during TACE and record possible feeding arteries. Observers will be blind to additional angio-grams obtained during TACE i.e selective DSA images of the segmental arteries and feeding arteries. observers will then evaluate the CT 3D images and record possible feeding arteries. The ''ground truth'' (GT) will be the gold standard tool and is obtained after completing the above mentioned analyses by allowing the observers to evaluate by consensus pre-embolization CT 2D and 3D images, all acquired DSA images during TACE , and post-lipiodol injection CT images if available. GT was used to define true-positive, false-positive, false-negative and true negative feeding vessels.

次要结局

  • inter-observer agreement(Baseline)

研究者

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

Ramy Mohammed Ahmed

lecturer of interventional and diagnostic radiology

Assiut University

研究点 (1)

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