The purpose of this study is to improve the diagnosis and management of hepatocellular adenoma.
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
- Hepatic and biliary neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
What is the sensitivity of CEUS with SonoVue compared to diagnostic modalities
conducted in the past (radiology, histology)?
Secondary outcome
What is the behavior of hepatocellular adenoma during and after menopause?
Is it possible to classify hepatocellular adenoma, according to the subgroups
of the Bordeaux group, based on contrast ultrasonography?
Are there specific biomarkers (natural peptides and metabolites) in urine that
can demonstrate hepatocellular adenoma?
What is the quality of life of patients with hepatocellular adenoma?
1. with certainty of hepatocellular adenoma (> 6 months ago)
2. who are in a diagnostic process for hepatocellular adenoma
Background summary
Contrast ultrasonagraphy is an easy and inexpensive imaging modality without
side effects. Using contrast ultrasonography, we believe we can make a clear
distinction between hepatocellular adenoma and focal nodular hyperplasia (a
benign tumour of the liver that generally does not require treatment and
follow-up, in contrast to hepatocellular adenoma). In the near future contrast
ultrasonography could be beneficial and could shorten the waiting time for
treatment. An easy and good method for identifying hepatocellular adenoma may
lead to a faster treatment. The purpose of this study is to improve the
diagnosis and management of hepatocellular adenoma.
Besides new imaging techniques, there are new technologies that improve the
diagnosis of adenomas in the field of expertise of biomarker. Human biological
fluids contain various types of biomarkers that can be specific and sensitive
for many diseases. Urine is a human sample that can be easily obtained. Using
mass spectrometry of urine, we hope to find specific biomarkers that can
demonstrate hepatocellular adenoma.
Study objective
The purpose of this study is to improve the diagnosis and management of
hepatocellular adenoma.
Study design
Patients aged 18 years and older, previously discharged from follow-up of the
Erasmus MC with the diagnosis or probable diagnosis of hapatocellular adenoma,
are eligible for the study. In the past, these patients were seen at the
surgery outpatient clinic and / or hepatogastroenterology outpatient clinic of
the Erasmus MC. After consent of the treating physician, patients will be asked
to participate in this study.
Patients will be informed after an official reflection period of 1 week. Blood
and urine samples of all patients will be collected. Besides that, all patients
will undergo contrast ultrasonography and patients will be asked to complete a
questionnaire.
Study burden and risks
Contrast ultrasonography takes about 20 minutes. Complications of the contrast
agents used in contrast ultrasonography contain allergic reactions in rare
cases. Serious adverse events of contrast ultrasonography may occur in <0.0002%
of cases. Venipuncture (venflon) will be conducted once. Collection of urine is
carried out by the patient. Patients will experience minimal impact of this
study, without additional risks.
's Gravendijkwal 230
3015 CE
NL
's Gravendijkwal 230
3015 CE
NL
Listed location countries
Age
Inclusion criteria
Persons 18 years and older, discharged from follow-up of the Erasmus MC with the diagnosis or probable diagnosis of hepatocellular adenoma. Informed consent must be signed.
Exclusion criteria
Persons under 18 years.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL34105.078.10 |