Short summary

This study was a descriptive cohort to establish a frame of reference for the elastometry of primary liver cancer, benign tumors and the surrounding cirrhotic tissue. Due to shortages of ressources and eligible patients, the project had to close before the anticipated number of patients were included. Due to the limited number of included patients no conclusions have been drawn from the primary study.

A derived project investigated changes in elastometry of the liver in patients ("liver stiffness") after a moderate- and high- calorie meal. None of the included patients in the meal test had liver cancer or bening liver nodules, but all had a liver biopsy and/or definite cirrhosis based on characteristic findings. Included patients belonged to one of three groups: no or minimal liver fibrosis, moderate or severe liver fibrosis, cirrhosis. All patients were investigated with liver and spleen elastography before and after a meal; on the first study day a moderate calorie meal, on the second study day a high calorie meal. This study was terminated in august 2015, after inclusion of 63 patients.

Rationale

Background:

Primary liver cancer (hepatocellular carcinoma) is the most common course of death among individuals diagnosed with compensated cirrhosis. Today ultrasound is used to screen for livercancer. Ultrasound is however not suitable for differentiating between benign and malignant liver nodules. Therefore patients with cirrhosis and a process in the liver will be referred to costly and a potentially high risk examinations such as CT-, MR-scan and biopsy. There is a need for secure, credible ultrasound based methods to establish whether a nodule in the liver is benign or malign.

Aixplorer (Supersonic, France) is a novel equipment that combines standard ultrasound with tissue elastography (stiffness measurements). Aixplorer is also able to estimate the stiffness of liver tumors. We know from a former study, that liver cancer stiffness differs from other types of liver tumors. Though these former studies doesn't examine whether or not the equipment can evaluate which tumors are benign and which are malignant.

Department of Medical Gastroenterology at Odense University Hospital is the first department in Denmark to invest in the Aixplorer equipment. ?

Aim:

The aim of this study is to describe the stiffness of primary liver cancer, benign tumors and the stiffness ratio between the tumors and the surrounding tissue. This study is a descriptive cohort and will be the preliminary study in a diagnostic test study.

Description of the cohort

This study will enroll sixty patients with cirrhosis. One half of the patients will be known with primary liver cancer, the other half will be known with benign liver tumors. All patients are scanned with Aixplorer and FibroScan (Echosens, France). The purpose of these scans is to establish a frame of reference for the elastometry for primary liver cancer, benign liver tumors and surrounding cirrhotic tissue. 

Data and biological material

The study collects the following data:

1. Participant baseline information: Cirrhosis etiology and stage, disease duration, age and other demographic data
2. Liver tumor information: Type of liver tumor, amount of tumors, situated, duration, diagnostic method, former treatment
3. Scan information: Tumor elastometry values, tumor peak-elastometry value, surrounding tissue elastometry values, nodule-to-tissue-ratio, conventional ultra sound description of the liver, elastometry of tissue with FibroScan?

Biological material for a biobank for future research to discover new markers for primary liver cancer: Blood samples, urine, saliva and faeces.

Collaborating researchers and departments

Department of Medical Gastrienterology, Odense University Hospital

• Postdoc Maja Thiele, MD
• Rozeta Abazi, MD
• Professor Aleksander Krag, PhD

Department of Surgery, Odense University Hospital

• Consultant Torsten Kjærulf Pless

Publications associated with the project

High risk of misinterpreting liver and spleen stiffness using 2D shear-wave and transient elastography after a moderate or high calorie meal. Kjærgaard M, Thiele M, Jansen C, et al. PLoS One. 2017;12(4):e0173992. Published 2017 Apr 4. doi:10.1371/journal.pone.0173992