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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.
Furumaya, Alicia; Haring, Martijn P D; van Rosmalen, Belle V; Klompenhouwer, Anne J; Besselink, Marc G; de Man, Robert A; IJzermans, Jan N M; Thomeer, Maarten G J; Kramer, Matthijs; Coolsen, Mariëlle M E; Tushuizen, Maarten E; Schaapherder, Alexander F; de Haas, Robbert J; Duiker, Evelien W; Kazemier, Geert; van Delden, Otto M; Verheij, Joanne; Takkenberg, R Bart; Cuperus, Frans J C; De Meijer, Vincent E; Erdmann, Joris I.
Afiliación
  • Furumaya A; Department of Surgery, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands.
  • Haring MPD; Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands.
  • van Rosmalen BV; Department of Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.
  • Klompenhouwer AJ; Department of Surgery, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands.
  • Besselink MG; Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands.
  • de Man RA; Department of Surgery, Erasmus Medical Center, Erasmus University Rotterdam, Rotterdam, The Netherlands.
  • IJzermans JNM; Department of Surgery, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands.
  • Thomeer MGJ; Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands.
  • Kramer M; Department of Gastroenterology and Hepatology, Erasmus Medical Center, Erasmus University Rotterdam, Rotterdam, The Netherlands.
  • Coolsen MME; Department of Surgery, Erasmus Medical Center, Erasmus University Rotterdam, Rotterdam, The Netherlands.
  • Tushuizen ME; Department of Radiology, Erasmus Medical Center, Erasmus University Rotterdam, Rotterdam, The Netherlands.
  • Schaapherder AF; Department of Gastroenterology and Hepatology, Maastricht University Medical Centre+, Maastricht University, Maastricht, The Netherlands.
  • de Haas RJ; Department of Surgery, Maastricht University Medical Centre+, Maastricht University, Maastricht, The Netherlands.
  • Duiker EW; Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden University, Leiden, The Netherlands.
  • Kazemier G; Department of Surgery, Leiden University Medical Center, Leiden University, Leiden, The Netherlands.
  • van Delden OM; Department of Radiology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.
  • Verheij J; Department of Pathology and Medical Biology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.
  • Takkenberg RB; Department of Surgery, Amsterdam UMC location Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
  • Cuperus FJC; Cancer Center Amsterdam, Amsterdam, the Netherlands.
  • De Meijer VE; Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands.
  • Erdmann JI; Department of Radiology, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands.
BMJ Open ; 12(9): e055104, 2022 09 08.
Article en En | MEDLINE | ID: mdl-36691222
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Adenoma de Células Hepáticas / Quistes / Neoplasias Hepáticas Tipo de estudio: Clinical_trials / Etiology_studies / Guideline / Incidence_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Aspecto: Ethics / Patient_preference Límite: Humans País/Región como asunto: Europa Idioma: En Revista: BMJ Open Año: 2022 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Adenoma de Células Hepáticas / Quistes / Neoplasias Hepáticas Tipo de estudio: Clinical_trials / Etiology_studies / Guideline / Incidence_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Aspecto: Ethics / Patient_preference Límite: Humans País/Región como asunto: Europa Idioma: En Revista: BMJ Open Año: 2022 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Reino Unido