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
,
Joanne Verheij,
Marc G Besselink,
Vincent E de Meijer,
Jan N M IJzermans,
D Ramsoekh,
C van der Leij,
Otto M van Delden,
Geert Kazemier,
Robert A de Man,
Frans J C Cuperus,
Martijn P D Haring,
Evelien W Duiker,
Robbert J de Haas,
R Bart Takkenberg,
Alicia Furumaya,
Belle V van Rosmalen,
Anne J Klompenhouwer,
Maarten G J Thomeer,
Matthijs Kramer,
Mariëlle M E Coolsen,
Maarten E Tushuizen,
Alexander F Schaapherder,
Joris I Erdmann,
ID Munsterman,
MD Doukas,
JC Beckervordersandforth,
R Miclea,
ETTL Tjwa,
PB van den Boezem,
JHW de Wilt,
S van Koeverden,
AE Braat,
MJ Coenraad,
SSLP Crobach,
S Feshtali,
MC Burgmans,
TM van Gulik,
R Swijnenburg,
KP de Jong
Affiliations
Joanne Verheij
Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands
Marc G Besselink
Department of Surgery, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
Vincent E de Meijer
Department of Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands
Jan N M IJzermans
Department of Surgery, Erasmus Medical Center, Erasmus University Rotterdam, Rotterdam, The Netherlands
D Ramsoekh
C van der Leij
Otto M van Delden
Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands
Geert Kazemier
Department of Surgery, Amsterdam UMC location Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
Robert A de Man
Department of Gastroenterology and Hepatology, Erasmus Medical Center, Erasmus University Rotterdam, Rotterdam, The Netherlands
Frans J C Cuperus
Department of Gastroenterology and Hepatology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands
Martijn P D Haring
Department of Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands
Evelien W Duiker
Department of Pathology and Medical Biology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands
Robbert J de Haas
Department of Radiology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands
R Bart Takkenberg
Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands
Alicia Furumaya
Department of Surgery, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
Belle V van Rosmalen
Department of Surgery, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
Anne J Klompenhouwer
Department of Surgery, Erasmus Medical Center, Erasmus University Rotterdam, Rotterdam, The Netherlands
Maarten G J Thomeer
Department of Radiology, Erasmus Medical Center, Erasmus University Rotterdam, Rotterdam, The Netherlands
Matthijs Kramer
Department of Gastroenterology and Hepatology, Maastricht University Medical Centre+, Maastricht University, Maastricht, The Netherlands
Mariëlle M E Coolsen
Department of Surgery, Maastricht University Medical Centre+, Maastricht University, Maastricht, The Netherlands
Maarten E Tushuizen
Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden University, Leiden, The Netherlands
Alexander F Schaapherder
Department of Surgery, Leiden University Medical Center, Leiden University, Leiden, The Netherlands
Joris I Erdmann
Department of Surgery, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
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.
