Pregnancy and liver adenoma management: PALM-study

BMC Gastroenterology

Study Protocol

Susanna M van Aalten¹  Turkan Terkivatan¹  Mirelle E E Bröker¹  Jan N M IJzermans¹  Robert A de Man²  Eric A P Steegers³  J J V Busschbach⁴  Ewout W Steyerberg⁵  Harry J de Koning⁵ 

[1] Departments of Surgery, Erasmus Medical Center, P.O. Box 2040, 3000, Rotterdam, CA, The Netherlands;Hepatogastroenterology, Erasmus Medical Center, P.O. Box 2040, 3000, Rotterdam, CA, The Netherlands;Obstetrics and Gynaecology, Erasmus Medical Center, P.O. Box 2040, 3000, Rotterdam, CA, The Netherlands;Psychology and Psychotherapy, Erasmus Medical Center, P.O. Box 2040, 3000, Rotterdam, CA, The Netherlands;Public Health, Erasmus Medical Center, P.O. Box 2040, 3000, Rotterdam, CA, The Netherlands;

关键词: Oral Contraceptive;    Pregnant Patient;    Elevated Liver Enzyme;    Spontaneous Rupture;    Hepatocellular Adenoma;   

DOI  :  10.1186/1471-230X-12-82

 received in 2012-04-19, accepted in 2012-06-16,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundHepatocellular adenoma (HCA) in pregnant women requires special considerations because of the risk of hormone induced growth and spontaneous rupture, which 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 behavior may be less threatening than presumed depends on the incidence of HCA growth and the subsequent clinical events during pregnancy.We aim to investigate the management and outcome of HCA during pregnancy and labor based on a prospectively acquired online database in the Netherlands.Methods/designThe Pregnancy And Liver adenoma Management (PALM) - study is a multicentre prospective study in three cohorts of pregnant patients. In total 50 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 at inclusion must not exceed 5 cm. The study group will be compared to a healthy control group of 63 pregnant patients and a group of 63 pregnant patients with diabetes mellitus without HCA. During their pregnancy HCA patients will be closely monitored by means of repetitive ultrasound (US) 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.DiscussionThe study will obtain information about the behaviour of HCA during pregnancy, the clinical consequences for mother and child and the impact of having a HCA during pregnancy on the health related quality of life of these young women. As a result of this study we will propose a decision-making model for the management of HCA during pregnancy.Trial registrationDutch trial register: NTR3034

【 授权许可】

Unknown   
© van Aalten et al.; licensee BioMed Central Ltd. 2012. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.