Hepatocellular adenoma (HCA) is rare benign tumor of the liver that occurs particularly in women during their reproductive years. The incidence is not exactly known. Studies performed years ago show an estimate incidence of 1-1.3 per 1,000,000 in women who have never used oral contraceptives (OC), compared to 30-40 per 1,000,000 in long-term users. Symptomatic patients with HCA present with right upper quadrant abdominal pain or discomfort secondary to bleeding within the HCA, elevated liver en
Conditions
Interventions
During their pregnancy hepatocellular adenoma (HCA) patients will be closely monitored by means of repetitive ultrasound (US) (and MRI in case of growth of the lesion) at 14 (+/- 3) and 20 and 26 and
Sponsors
Erasmus University Medical Center Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: Study groep: 1. Properly Dutch speaking, pregnant patients; 2. 18 years of age or older; 3. A radiologically and/or histologically proven diagnosis of hepatocellular adenoma. Radiological diagnosis of HCA will be based on contrast enhanced magnetic resonance imaging. Lesions must not exceed 5 cm; 4. Informed consent must be signed. First control group: 1. Properly Dutch speaking, healthy pregnant patients; 2. 18 years of age or older; 3. Without hepatocellular adenoma (presenting at the practicing midwife); 4. Informed consent must be signed. Second control group: 1. Properly Dutch speaking, pregnant patients; 2. 18 years of age or older; 3. Diabetes Mellitus (presenting at the obstetrician); 4. Informed consent must be signed.
Exclusion criteria
Exclusion criteria: Dementia or impaired mental function that would counter the understanding of giving informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the incidence of hepatocellular adenoma growth during pregnancy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To investigate in which trimester of pregnancy growth of hepatocellular adenoma (HCA) occurs; 2. To investigate the degree of growth of HCA during pregnancy; 3. To investigate whether there is regression of HCA postpartum; 4. To investigate the HCA-related interventions during pregnancy; 5. To investigate the incidence of bleeding of HCA during pregnancy; 6. To investigate liver-related clinical signs during pregnancy; 7. To investigate elevated liver enzymes during pregnancy; 8. To evaluate the quality of life of pregnant patients with HCA; 9. To investigate whether there is a difference between quality of life of pregnant patients with HCA and pregnant patients with other comorbidity that have an indication for pregnancy care at the obstetrician in secondary care and healthy pregnant patients. | — |
Contacts
Public ContactJ.N.M. IJzermans
Erasmus University Medical Center PO Box 2040
Outcome results
None listed