Study protocol for a multicentre nationwide prospective cohort study to investigate the natural course and clinical outcome in benign liver tumours and cysts in the Netherlands: the BELIVER study
BMJ Open, vol. 12, pp. e055104
Abstract
INTRODUCTION: Benign liver tumours and cysts (BLTCs) comprise a heterogeneous group of cystic and solid lesions, including hepatic haemangioma, focal nodular hyperplasia and hepatocellular adenoma. Some BLTCs, for example, (large) hepatocellular adenoma, are at risk of complications. Incidence of malignant degeneration or haemorrhage is low in most other BLTCs. Nevertheless, the diagnosis BLTC may carry a substantial burden and patients may be symptomatic, necessitating treatment. The indications for interventions remain matter of debate. The primary study aim is to investigate patient-reported outcomes (PROs) of patients with BLTCs, with special regards to the influence of invasive treatment as compared with the natural course of the disease. METHODS AND ANALYSIS: A nationwide observational cohort study of patients with BLTC will be performed between October 2021 and October 2026, the minimal follow-up will be 2 years. During surveillance, a questionnaire regarding symptoms and their impact will be sent to participants on a biannual basis and more often in case of invasive intervention. The questionnaire was previously developed based on PROs considered relevant to patients with BLTCs and their caregivers. Most questionnaires will be administered by computerised adaptive testing through the Patient-Reported Outcomes Measurement Information System. Data, such as treatment outcomes, will be extracted from electronic patient files. Multivariable analysis will be performed to identify patient and tumour characteristics associated with significant improvement in PROs or a complicated postoperative course. ETHICS AND DISSEMINATION: The study was assessed by the Medical Ethics Committee of the University Medical Center Groningen and the Amsterdam UMC. Local consultants will provide information and informed consent will be asked of all patients. Results will be published in a peer-reviewed journal. STUDY REGISTRATION: NL8231-10 December 2019; Netherlands Trial Register.
Authors 21
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Amsterdam UMC Location University of Amsterdam · Amsterdam Gastroenterology Endocrinology Metabolism
Affiliation as printed
Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands
Department of Surgery, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
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University Medical Center Groningen · University of Groningen
Affiliation as printed
Department of Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands
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Amsterdam UMC Location University of Amsterdam · Amsterdam Gastroenterology Endocrinology Metabolism
Affiliation as printed
Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands
Department of Surgery, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
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Erasmus MC · Erasmus University Rotterdam
Affiliation as printed
Department of Surgery, Erasmus Medical Center, Erasmus University Rotterdam, Rotterdam, The Netherlands
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Amsterdam UMC Location University of Amsterdam · Amsterdam Gastroenterology Endocrinology Metabolism
Affiliation as printed
Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands
Department of Surgery, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
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Erasmus MC · Erasmus University Rotterdam
Affiliation as printed
Department of Gastroenterology and Hepatology, Erasmus Medical Center, Erasmus University Rotterdam, Rotterdam, The Netherlands
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Erasmus MC · Erasmus University Rotterdam
Affiliation as printed
Department of Surgery, Erasmus Medical Center, Erasmus University Rotterdam, Rotterdam, The Netherlands
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Erasmus MC · Erasmus University Rotterdam
Affiliation as printed
Department of Radiology, Erasmus Medical Center, Erasmus University Rotterdam, Rotterdam, The Netherlands
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Maastricht University Medical Centre · Maastricht University
Affiliation as printed
Department of Gastroenterology and Hepatology, Maastricht University Medical Centre+, Maastricht University, Maastricht, The Netherlands
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Maastricht University Medical Centre · Maastricht University
Affiliation as printed
Department of Surgery, Maastricht University Medical Centre+, Maastricht University, Maastricht, The Netherlands
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Leiden University · Leiden University Medical Center
Affiliation as printed
Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden University, Leiden, The Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Surgery, Leiden University Medical Center, Leiden University, Leiden, The Netherlands
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University Medical Center Groningen · University of Groningen
Affiliation as printed
Department of Radiology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands
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University Medical Center Groningen · University of Groningen
Affiliation as printed
Department of Pathology and Medical Biology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands
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Cancer Center Amsterdam · Amsterdam UMC Location Vrije Universiteit Amsterdam
Affiliation as printed
Cancer Center Amsterdam, Amsterdam, the Netherlands
Department of Surgery, Amsterdam UMC location Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
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Amsterdam UMC Location University of Amsterdam · Amsterdam Gastroenterology Endocrinology Metabolism
Affiliation as printed
Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands
Department of Radiology, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
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Amsterdam UMC Location University of Amsterdam · Amsterdam Gastroenterology Endocrinology Metabolism
Affiliation as printed
Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands
Department of Pathology, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
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Amsterdam UMC Location University of Amsterdam · Amsterdam Gastroenterology Endocrinology Metabolism
Affiliation as printed
Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands
Department of Gastroenterology and Hepatology, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
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University Medical Center Groningen · University of Groningen
Affiliation as printed
Department of Gastroenterology and Hepatology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands
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University Medical Center Groningen · University of Groningen
Affiliation as printed
Department of Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands
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Joris I. Erdmann corresponding
Amsterdam UMC Location University of Amsterdam · Amsterdam Gastroenterology Endocrinology Metabolism
Affiliation as printed
Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands
Department of Surgery, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
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