PDF(Pubmed)
Abstract：
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.
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.
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.
NL8231-10 December 2019; Netherlands Trial Register.
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.
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.
NL8231-10 December 2019; Netherlands Trial Register.
摘要：
背景：良性肝肿瘤和囊肿（BLTC）包括一组囊性和实性病变，包括肝血管瘤,局灶性结节增生和肝细胞腺瘤。一些BLTC,例如,（大）肝细胞腺瘤，有并发症的风险。在大多数其他BLTC中，恶性变性或出血的发生率较低。然而，诊断BLTC可能会带来巨大的负担，患者可能有症状，需要治疗。干预的迹象仍然是辩论的问题。主要研究目的是调查BLTC患者的患者报告结果（PRO），与疾病的自然病程相比，特别考虑到侵入性治疗的影响。
方法：一项针对BLTC患者的全国性观察性队列研究将于2021年10月至2026年10月之间进行，最低随访时间为2年。在监视期间,有关症状及其影响的问卷将每两年一次发送给参与者，并且在进行侵入性干预的情况下更为常见。该问卷以前是根据被认为与BLTC患者及其护理人员相关的PRO制定的。大多数问卷将通过患者报告结果测量信息系统通过计算机自适应测试进行管理。数据,例如治疗结果，将从电子病人档案中提取。将进行多变量分析，以确定与PROs显着改善或复杂的术后过程相关的患者和肿瘤特征。
背景：该研究由格罗宁根大学医学中心和阿姆斯特丹UMC的医学伦理委员会进行评估。当地顾问将提供信息，并询问所有患者的知情同意。结果将发表在同行评审的期刊上。
背景：NL8231-2019年12月10日；荷兰试验注册。
方法：一项针对BLTC患者的全国性观察性队列研究将于2021年10月至2026年10月之间进行，最低随访时间为2年。在监视期间,有关症状及其影响的问卷将每两年一次发送给参与者，并且在进行侵入性干预的情况下更为常见。该问卷以前是根据被认为与BLTC患者及其护理人员相关的PRO制定的。大多数问卷将通过患者报告结果测量信息系统通过计算机自适应测试进行管理。数据,例如治疗结果，将从电子病人档案中提取。将进行多变量分析，以确定与PROs显着改善或复杂的术后过程相关的患者和肿瘤特征。
背景：该研究由格罗宁根大学医学中心和阿姆斯特丹UMC的医学伦理委员会进行评估。当地顾问将提供信息，并询问所有患者的知情同意。结果将发表在同行评审的期刊上。
背景：NL8231-2019年12月10日；荷兰试验注册。
