PDF(Pubmed)
Abstract：
BACKGROUND: The presence of spontaneous portosystemic shunts (SPSS) has been identified to be associated with hepatic encephalopathy (HE) in patients with cirrhosis. Nevertheless, the role of interventional embolisation in managing such patients remains poorly defined. Consequently, this prospective controlled study aims to assess the efficacy and safety of interventional embolisation as a therapeutic approach for patients with cirrhosis and recurrent or persistent HE related to SPSS.
METHODS: Cirrhotic patients diagnosed with recurrent or persistent HE associated with SPSS will be recruited for this study, and assigned to either the interventional embolisation group or the standard medical treatment group. The efficacy endpoints encompass the evaluation of postoperative alleviation of HE symptoms and the incidence of overt HE recurrence during the follow-up period, as well as the duration and frequency of hospitalisations for HE, alterations in liver function and volume, and overall survival. The safety endpoints encompass both immediate and long-term postoperative complications.
BACKGROUND: This study will be conducted in strict adherence to the principles of good clinical practice and the guidelines outlined in the Declaration of Helsinki. Ethical approval for the trial has been obtained from the Ethics Committee of Mengchao Hepatobiliary Hospital of Fujian Medical University (2023_013_02). Written informed consent will be obtained from all the participants by the treating physician for each patient prior to their enrolment. The documented informed consent forms will be retained as part of the clinical trial records for future reference. The study findings will be disseminated through publication in peer-reviewed journals and will be presented at international conferences.
BACKGROUND: ChiCTR2300072189.
METHODS: Cirrhotic patients diagnosed with recurrent or persistent HE associated with SPSS will be recruited for this study, and assigned to either the interventional embolisation group or the standard medical treatment group. The efficacy endpoints encompass the evaluation of postoperative alleviation of HE symptoms and the incidence of overt HE recurrence during the follow-up period, as well as the duration and frequency of hospitalisations for HE, alterations in liver function and volume, and overall survival. The safety endpoints encompass both immediate and long-term postoperative complications.
BACKGROUND: This study will be conducted in strict adherence to the principles of good clinical practice and the guidelines outlined in the Declaration of Helsinki. Ethical approval for the trial has been obtained from the Ethics Committee of Mengchao Hepatobiliary Hospital of Fujian Medical University (2023_013_02). Written informed consent will be obtained from all the participants by the treating physician for each patient prior to their enrolment. The documented informed consent forms will be retained as part of the clinical trial records for future reference. The study findings will be disseminated through publication in peer-reviewed journals and will be presented at international conferences.
BACKGROUND: ChiCTR2300072189.
摘要：
背景：已确定自发性门体分流（SPSS）的存在与肝硬化患者的肝性脑病（HE）有关。然而，介入栓塞术在治疗此类患者中的作用尚不明确.因此,这项前瞻性对照研究旨在评估介入栓塞治疗肝硬化和SPSS相关复发性或持续性HE的疗效和安全性.
方法：本研究将招募诊断为与SPSS相关的复发性或持续性HE的肝硬化患者。并分配到介入栓塞组或标准药物治疗组。疗效终点包括评估术后HE症状的缓解和随访期间明显HE复发的发生率，以及HE的住院时间和频率，肝功能和体积的改变，和总体生存率。安全性终点包括术后即刻和长期并发症。
背景：本研究将严格遵守良好的临床实践原则和《赫尔辛基宣言》中概述的指南。该试验已获得福建医科大学孟超肝胆医院伦理委员会的伦理批准(2023_013_02)。在招募之前，每位患者的治疗医生将从所有参与者那里获得书面知情同意书。记录的知情同意书将作为临床试验记录的一部分保留，以备将来参考。研究结果将通过发表在同行评审的期刊上传播，并将在国际会议上发表。
背景：ChiCTR2300072189。
方法：本研究将招募诊断为与SPSS相关的复发性或持续性HE的肝硬化患者。并分配到介入栓塞组或标准药物治疗组。疗效终点包括评估术后HE症状的缓解和随访期间明显HE复发的发生率，以及HE的住院时间和频率，肝功能和体积的改变，和总体生存率。安全性终点包括术后即刻和长期并发症。
背景：本研究将严格遵守良好的临床实践原则和《赫尔辛基宣言》中概述的指南。该试验已获得福建医科大学孟超肝胆医院伦理委员会的伦理批准(2023_013_02)。在招募之前，每位患者的治疗医生将从所有参与者那里获得书面知情同意书。记录的知情同意书将作为临床试验记录的一部分保留，以备将来参考。研究结果将通过发表在同行评审的期刊上传播，并将在国际会议上发表。
背景：ChiCTR2300072189。
