Management van leveradenomen gedurende de zwangerschap.

Aim:

Hepatocellular adenoma (HCA) in pregnant women requires special considerations because of the risk of hormone induced growth and spontaneous rupture, due to increased levels of steroid hormones during pregnancy that may threaten the life of both mother and child. Due to scarcity of cases there is no evidence-based algorithm for the evaluation and management of HCA during pregnancy. Most experts advocate that women with HCA should not get pregnant or advise surgical resection before pregnancy. Whether it is justified to deny a young woman a pregnancy, as the biological behaviour may be less threatening than presumed depends on the incidence of HCA growth during pregnancy. We aim to investigate the management and outcome of HCA during pregnancy based on a prospectively acquired online database in the Netherlands.



Methods:

The Pregnancy And Liver adenoma Management (PALM) - study starts on November 1 2011 and inclusion of patients will be a period of 3 to 5 years. The PALM-study is a multicentre prospective study in three cohorts of pregnant patients. In total 100 pregnant patients, ≥ 18 years of age with a radiologically and/or histologically proven diagnosis of HCA will be included in the study. Radiological diagnosis of HCA will be based on contrast enhanced MRI. Lesions must not exceed 5 cm. The study group will be compared to a healthy control group consisting of 63 pregnant patients, ≥ 18 years of age without HCA and a group consisting of 63 pregnant patients, ≥ 18 years of age with diabetes mellitus without HCA. During their pregnancy HCA patients will be closely monitored by means of repetitive ultrasound (US) (and MRI in case of growth of the lesion(s)) at 14, 20, 26, 32 and 38 weeks of gestation and 6 and 12 weeks postpartum. Both control groups will undergo US of the liver at 14 weeks of gestation to exclude HCA lesions in the liver. All groups will be asked to fill out quality of life related questionnaires at 14, 20, 26, 32 and 38 weeks of gestation and 6 and 12 weeks postpartum. We established a website which allows hepatologists, surgeons and gyneacologists to submit clinical data in an online database.



Conclusion:

The hypothesis is that pregnancy may be allowed in case of one or more known HCA < 5 cm (without previous intervention), because HCA < 5 cm will not disturb the course of pregnancy. Our main point of interest is whether it is justified to deny a young woman a pregnancy. With this study we hope to obtain information about the behaviour of HCA during pregnancy and the impact of HCA during pregnancy on the life of these young women and besides to propose a decision-making model for the management of HCA during pregnancy.

Hepatocellular adenoma in pregnant women requires special considerations because of the risk of hormone induced growth and spontaneous rupture, due to increased levels of steroid hormones during pregnancy that may threaten the life of both mother and child. Most experts advocate that women with hepatocellular adenoma should not get pregnant or advise surgical resection before pregnancy. We recently proposed not to discourage all women with hepatocellular adenoma from pregnancy, based on a study in which we monitored twelve women with documented hepatocellular adenoma during a total of 17 pregnancies. In 4 cases hepatocellular adenomas grew during pregnancy, requiring a Caesarean section in 1 patient (2 pregnancies) and radiofrequency ablation in 1 case during the first trimester of pregnancy. All pregnancies had an uneventful course with a successful maternal and fetal outcome. However, there is no evidence-based algorithm for the evaluation and management of hepatocellular adenoma during pregnancy, due to scarcity of cases. The conclusion not to discourage all women with hepatocellular adenoma from pregnancy has, however, to be proven in a large multicentre study in which we will closely monitor pregnant patient with a hepatocellular adenoma in a prospectively acquired database to give more insight in the behaviour of hepatocellular adenoma during pregnancy.



Hypothesis:

Pregnancy may be allowed in case of one or more known hepatocellular adenoma < 5 cm (without previous intervention), because hepatocellular adenoma < 5 cm will not disturb the course of pregnancy.



Disrupted course of pregnancy:

1. Interventions during pregnancy (radiological and/or surgical intervention);

2. Anxiety in patients during pregnancy related to the presence of HCA in the liver and possible growth during pregnancy.

14 (+/- 3) and 20 and 26 and 32 and 38 weeks of gestation and 6 and 12 weeks postpartum.

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 32 and 38 weeks of gestation and 6 and 12 weeks postpartum. At the same days both control groups will be asked to fill out the SF-12 and EQ-5d questionnaire at 14 (+/- 3) and 20 and 26 and 32 and 38 weeks of gestation and at 6 and 12 weeks postpartum. The study group will be asked to fill out the SF-12, EQ-5d, STAI-6 and IES questionnaires before and one week after US of the HCA lesion(s). Both control groups will undergo US of the liver at 14 (+/- 3) weeks of gestation to exclude HCA lesions in the liver. At 14 and 32 weeks of pregnancy all patient groups will undergo venapunction.