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
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 mal...
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| Format: | Article |
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BMJ Publishing Group
2022-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/9/e055104.full |
| _version_ | 1811210546138054656 |
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| author | 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 |
| author_facet | 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 |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-12T04:57:35Z |
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| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-12T04:57:35Z |
| publishDate | 2022-09-01 |
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| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-f9b8ce3ac97445dc82eff5ff2edfbce12022-12-22T03:47:06ZengBMJ Publishing GroupBMJ Open2044-60552022-09-0112910.1136/bmjopen-2021-055104Study 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 Verheij0Marc G Besselink1Vincent E de Meijer2Jan N M IJzermans3D RamsoekhC van der LeijOtto M van Delden4Geert Kazemier5Robert A de Man6Frans J C Cuperus7Martijn P D Haring8Evelien W Duiker9Robbert J de Haas10R Bart Takkenberg11Alicia Furumaya12Belle V van Rosmalen13Anne J Klompenhouwer14Maarten G J Thomeer15Matthijs Kramer16Mariëlle M E Coolsen17Maarten E Tushuizen18Alexander F Schaapherder19Joris I Erdmann20ID MunstermanMD DoukasJC BeckervordersandforthR MicleaETTL TjwaPB van den BoezemJHW de WiltS van KoeverdenAE BraatMJ CoenraadSSLP CrobachS FeshtaliMC BurgmansTM van GulikR SwijnenburgKP de JongAmsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The NetherlandsDepartment of Surgery, Amsterdam UMC location University of Amsterdam, Amsterdam, The NetherlandsDepartment of Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The NetherlandsDepartment of Surgery, Erasmus Medical Center, Erasmus University Rotterdam, Rotterdam, The NetherlandsAmsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The NetherlandsDepartment of Surgery, Amsterdam UMC location Vrije Universiteit Amsterdam, Amsterdam, The NetherlandsDepartment of Gastroenterology and Hepatology, Erasmus Medical Center, Erasmus University Rotterdam, Rotterdam, The NetherlandsDepartment of Gastroenterology and Hepatology, University Medical Centre Groningen, University of Groningen, Groningen, The NetherlandsDepartment of Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The NetherlandsDepartment of Pathology and Medical Biology, University Medical Centre Groningen, University of Groningen, Groningen, The NetherlandsDepartment of Radiology, University Medical Centre Groningen, University of Groningen, Groningen, The NetherlandsAmsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The NetherlandsDepartment of Surgery, Amsterdam UMC location University of Amsterdam, Amsterdam, The NetherlandsDepartment of Surgery, Amsterdam UMC location University of Amsterdam, Amsterdam, The NetherlandsDepartment of Surgery, Erasmus Medical Center, Erasmus University Rotterdam, Rotterdam, The NetherlandsDepartment of Radiology, Erasmus Medical Center, Erasmus University Rotterdam, Rotterdam, The NetherlandsDepartment of Gastroenterology and Hepatology, Maastricht University Medical Centre+, Maastricht University, Maastricht, The NetherlandsDepartment of Surgery, Maastricht University Medical Centre+, Maastricht University, Maastricht, The NetherlandsDepartment of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden University, Leiden, The NetherlandsDepartment of Surgery, Leiden University Medical Center, Leiden University, Leiden, The NetherlandsDepartment of Surgery, Amsterdam UMC location University of Amsterdam, Amsterdam, The NetherlandsIntroduction 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.https://bmjopen.bmj.com/content/12/9/e055104.full |
| spellingShingle | 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 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/12/9/e055104.full |
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