Project

Liver metastasis in colorectal carcinoma: Accuracy of Contrast-enhanced ultrasound (CEUS) in comparison with computertomography on new diagnosed CRC with impact on therapy strategy?

Automatically Closed · 2015 until 2018

Type
Clinical Studies
Range
Monocentric project at KSSG
Units
Status
Automatically Closed
Start Date
2015
End Date
2018
Financing
KSSG
Study Design
Prospektive single-Center Kohortenstudie
Brief description/objective

Background: Up to 20% of liver metastasis could be missed by CT according to the oncological staging in colorectal carcinoma
Primary endpoint: Detection of colorectal liver metastasis (CRLM) – comparison of CEUS with CT (hypothesis CEUS with better sensitivity,
decreasing false-negative results in CT)
Secondary endpoints:
a) in case of unclear focal liver lesion (FLL) in CT accuracy of CEUS in differentiation in malignant (metastasis) and benign FLL
b) in case of better sensitivity in CEUS: number of patients with modified oncological therapy strategy due to additional detected CRLM by CEUS
c) evaluation of number need to detect additional liver metastasis (for CEUS)
Inclusion/Exclusion critera:
Patients with new diagnosed CRC by colonoscopy and histology without CRLM in CT or unclear FLL in CT.
Exlusion criteria: no informed consent, known allergy on CT or CEUS - contrast agent, pregnancy, severe asthma bronchiale, acute myocardial infarction, acute coronary syndrome, heart failure (NYHA IV), cirrhosis. No vulnerable participants.
Procedures: CEUS with i.v. contrast agent by three gastroenterologists. Documentation of arterial enhancement and wash out is interpretated as malignant FLL (liver metastasis). CT results are documented independently by radiologists without knowledge of CEUS results.
*Standard of reference (SOR) are congruent results of CT & CEUS (= correct differentiation between benign and malignant FLL). In case of divergent results biopsy is required. In case of no informed consent for biopsy or contraindications a MRI is performed. Statistical data analysis by the CTU.