Henderson J Michael, Boyer Thomas D, Kutner Michael H, Galloway John R, Rikkers Layton F, Jeffers Lennox J, Abu-Elmagd Kareem, Connor Jason
Department of Surgery, Cleveland Clinic, Cleveland, Ohio, USA.
Gastroenterology. 2006 May;130(6):1643-51. doi: 10.1053/j.gastro.2006.02.008.
BACKGROUND & AIMS: Variceal bleeding refractory to medical treatment with beta-blockers and endoscopic therapy can be managed by variceal decompression with either surgical shunts or transjugular intrahepatic portal systemic shunts (TIPS). This prospective randomized trial tested the hypothesis that patients receiving distal splenorenal shunts (DSRS) would have significantly lower rebleeding and encephalopathy rates than TIPS in management of refractory variceal bleeding.
A prospective randomized controlled clinical trial at 5 centers was conducted. One hundred forty patients with Child-Pugh class A and B cirrhosis and refractory variceal bleeding were randomized to DSRS or TIPS. Protocol and event follow-up for 2-8 years (mean, 46 +/- 26 months) for primary end points of variceal bleeding and encephalopathy and secondary end points of death, ascites, thrombosis and stenosis, liver function, need for transplant, quality of life, and cost were evaluated.
There was no significant difference in rebleeding (DSRS, 5.5%; TIPS, 10.5%; P = .29) or first encephalopathy event (DSRS, 50%; TIPS, 50%). Survival at 2 and 5 years (DSRS, 81% and 62%; TIPS, 88% and 61%, respectively) were not significantly different (P = .87). Thrombosis, stenosis, and reintervention rates (DSRS, 11%; TIPS, 82%) were significantly (P < .001) higher in the TIPS group. Ascites, need for transplant, quality of life, and costs were not significantly different.
DSRS and TIPS are similarly efficacious in the control of refractory variceal bleeding in Child-Pugh class A and B patients. Reintervention is significantly greater for TIPS compared with DSRS. Because both procedures have equivalent outcomes, the choice is dependent on available expertise and ability to monitor the shunt and reintervene when needed.
对于使用β受体阻滞剂和内镜治疗难以控制的静脉曲张出血,可通过外科分流术或经颈静脉肝内门体分流术(TIPS)进行静脉曲张减压治疗。这项前瞻性随机试验检验了以下假设:在治疗难治性静脉曲张出血方面,接受远端脾肾分流术(DSRS)的患者再出血率和肝性脑病发生率显著低于接受TIPS的患者。
在5个中心进行了一项前瞻性随机对照临床试验。140例Child-Pugh A级和B级肝硬化且静脉曲张出血难治的患者被随机分为DSRS组或TIPS组。对静脉曲张出血和肝性脑病等主要终点以及死亡、腹水、血栓形成和狭窄、肝功能、移植需求、生活质量和成本等次要终点进行了2至8年(平均46±26个月)的方案和事件随访评估。
再出血率(DSRS组为5.5%;TIPS组为10.5%;P = 0.29)或首次肝性脑病事件发生率(DSRS组为50%;TIPS组为50%)无显著差异。2年和5年生存率(DSRS组分别为81%和62%;TIPS组分别为88%和61%)无显著差异(P = 0.87)。TIPS组的血栓形成、狭窄和再次干预率(DSRS组为11%;TIPS组为82%)显著更高(P < 0.001)。腹水、移植需求、生活质量和成本无显著差异。
DSRS和TIPS在控制Child-Pugh A级和B级患者难治性静脉曲张出血方面疗效相似。与DSRS相比,TIPS的再次干预需求显著更高。由于两种手术效果相当,选择取决于现有的专业技术以及监测分流和在需要时进行再次干预的能力。