Symptomatic Abdominal Tumour Clinical Trial
Official title:
To Evaluate the Safety and Efficacy of High-intensity Focused Ultrasound (HIFU) for the Symptom Relief of Inoperable Abdominal Tumors
High-intensity focused ultrasound (HIFU), a recently developed tumor ablation equipment, can be a non-invasive treatment for solid tumors. The principle of HIFU is physically focus the ultrasound point on the biological tissue to form high-intensity ultrasound focus, and kill tumor cells by the thermal effects, mechanical effects and acupuncture effects of the high-intensity ultrasound.
The clinical recommendations for unresectable malignant tumors, which cause pain and other
symptoms, are chemotherapy or local radiation therapy to delay tumor progression, improve
life quality and prolong survival, while there is no other effective recommendations for
benign tumors., Local ablation, such as radiofrequency ablation (RFA), is expected to be
another therapeutic option for tumors that cannot be surgically resected. However, the main
drawback of radiofrequency ablation is that its puncture invasion can sometimes cause
bleeding or tumor metastasis. The peripheral blood vessels can also cause poor ablation,
therefore; RFA is limited to small liver cancer treatment.
High-intensity focused ultrasound (HIFU), a recently developed tumor ablation equipment, can
be a non-invasive treatment for solid tumors. The principle of HIFU is physically focus the
ultrasound point on the biological tissue to form high-intensity ultrasound focus, and kill
tumor cells by the thermal effects, mechanical effects and acupuncture effects of the
high-intensity ultrasound.
Under the real-time magnetic resonance imaging system and a variety of appropriate scanning
to move the focused ultrasound in the treatment area to kill the tumor. The tumor that is
killed will gradually absorb and fibrosis in the body. There is no significant invasion due
to it is without penetrating the needle into body. This system has been approved and
certificated for the use of soft tissue ablation by Taiwan Food and Drug Administration
(TFDA) in 2016. The main participants of this study are patients who have benign and
malignant tumors in the abdominal cavity with tumor-related symptoms and not suitable for
surgical resection. The investigators will conduct HIFU, observe whether there is any
complications after surgery. Moreover, the investigators will notice the tumor response after
a month and track the survival rate to verify the feasibility and advantages of HIFU for
clinical use.
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