Department of Liver Disease and Digestive Interventional Radiology, Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.
BMJ Open. 2013 Jul 11;3(7). doi: 10.1136/bmjopen-2013-003370. Print 2013.
Portal vein thrombosis (PVT) increases the risk of variceal rebleeding in liver cirrhosis. However, the strategy for preventing variceal rebleeding in cirrhotic patients with PVT has not been explored. This study aims to evaluate whether the transjugular intrahepatic portosystemic shunt (TIPS) or conventional therapy is preferable for the prevention of variceal rebleeding in liver cirrhosis patients with PVT.
This is a randomised controlled trial comparing the safety and efficacy of TIPS versus conventional therapy (ie, endoscopic therapy combined with non-selective β-blockers and anticoagulants) for the prevention of variceal rebleeding in cirrhotic patients with non-tumoral PVT. A total of 50 cirrhotic patients with PVT (thrombus >50% of portal vein lumen occupancy) and a history of variceal bleeding will be stratified according to the Child-Pugh class and degree of PVT, and randomised into the TIPS and conventional therapy groups. The primary objective was to compare the incidence of variceal rebleeding between the two groups. The secondary objectives were to compare the overall mortality, variceal rebleeding-related mortality, portal vein recanalisation and complications between the two groups, and to observe the progression of PVT in patients without portal vein recanalisation.
This study was approved by the ethics committee of Xijing hospital (No. 20110224-5), and was registered at ClinicalTrials.gov (NCT01326949). All participants give written informed consent. The first patient was recruited into our study on 4 June 2011. A total of 29 patients were recruited through 5 March 2013 (14 and 15 patients assigned to the TIPS and conventional therapy groups, respectively). If TIPS is superior to conventional therapy for the prevention of variceal rebleeding in cirrhotic patients with PVT, TIPS might be recommended as the first-line therapy in such patients. But a small sample size potentially limits the generalisation of our conclusions.
This study was registered at ClinicalTrials.gov on 29 March 2011. The trial registration number is NCT01326949.
The first patient was recruited into our study on 4 June 2011. A total of 29 patients were recruited through 5 March 2013 (14 and 15 patients assigned to the TIPS and conventional therapy groups, respectively).
门静脉血栓形成（PVT）增加了肝硬化患者静脉曲张再出血的风险。然而，对于合并 PVT 的肝硬化患者，预防静脉曲张再出血的策略尚未得到探索。本研究旨在评估经颈静脉肝内门体分流术（TIPS）与常规治疗（即内镜治疗联合非选择性β受体阻滞剂和抗凝剂）预防 PVT 合并肝硬化患者静脉曲张再出血的效果。
这是一项比较 TIPS 与常规治疗（即内镜治疗联合非选择性β受体阻滞剂和抗凝剂）预防非肿瘤性 PVT 合并肝硬化患者静脉曲张再出血的安全性和疗效的随机对照试验。共纳入 50 例 PVT（血栓占门静脉管腔>50%）且有静脉曲张出血史的肝硬化患者，根据 Child-Pugh 分级和 PVT 程度进行分层，随机分为 TIPS 组和常规治疗组。主要终点为两组静脉曲张再出血发生率。次要终点为两组总死亡率、静脉曲张再出血相关死亡率、门静脉再通率和并发症，以及观察无门静脉再通患者 PVT 的进展情况。
本研究经西京医院伦理委员会批准（编号：20110224-5），并在 ClinicalTrials.gov 注册（NCT01326949）。所有参与者均签署书面知情同意书。首例患者于 2011 年 6 月 4 日入组。截至 2013 年 3 月 5 日，共入组 29 例患者（TIPS 组和常规治疗组各 14 例和 15 例）。如果 TIPS 预防 PVT 合并肝硬化患者静脉曲张再出血优于常规治疗，TIPS 可能被推荐为此类患者的一线治疗方法。但小样本量可能限制了研究结论的推广。
本研究于 2011 年 3 月 29 日在 ClinicalTrials.gov 注册，试验注册号为 NCT01326949。
首例患者于 2011 年 6 月 4 日入组。截至 2013 年 3 月 5 日，共入组 29 例患者（TIPS 组和常规治疗组各 14 例和 15 例）。
