内镜治疗及经颈静脉肝内门体分流术与门腔分流术治疗肝硬化胃静脉曲张出血的急诊及择期治疗的随机试验
Randomized trials of endoscopic therapy and transjugular intrahepatic portosystemic shunt versus portacaval shunt for emergency and elective treatment of bleeding gastric varices in cirrhosis.
作者信息
Orloff Marshall J, Hye Robert J, Wheeler Henry O, Isenberg Jon I, Haynes Kevin S, Vaida Florin, Girard Barbara, Orloff Karen J
机构信息
Department of Surgery, University of California, San Diego Medical Center, San Diego, CA.
Department of Surgery, University of California, San Diego Medical Center, San Diego, CA.
出版信息
Surgery. 2015 Jun;157(6):1028-45. doi: 10.1016/j.surg.2014.12.003.
IMPORTANCE
Bleeding esophageal varices has been studied extensively, but bleeding gastric varices (BGV) has received much less investigation. However, BGV has been reported in ≤ 30% of patients with acute variceal bleeding. In our studies of 1,836 bleeding cirrhotics, 12.7% were bleeding from gastric varices. BGV mortality rate of 45-55% has been reported. The BGV literature has mainly involved retrospective case reports, often with short-term follow-up.
OBJECTIVE
We sought to describe the results of a prospective, randomized, controlled trial (RCT) in unselected, consecutive patients with BGV comparing endoscopic therapy (ET) with portacaval shunt (PCS; n = 518), and later comparing emergency transjugular intrahepatic portosystemic shunt (TIPS) with emergency portacaval shunt (EPCS; n = 70).
DESIGN, SETTING, AND PARTICIPANTS: Initially, our RCT involved 518 patients with BGV comparing ET with direct PCS regarding control of bleeding, mortality rate, and disability. When entry of patients ended, the RCT was expanded to compare emergency TIPS with EPCS (n = 70). This RCT of BGV was separate from our other RCTs of bleeding esophageal varices.
INTERVENTIONS
Initially, ET was compared with PCS. In the second part of our RCT, emergency TIPS was compared with emergency PCS (EPCS).
MAIN OUTCOME MEASURES
Outcomes were survival, control of bleeding, portal-systemic encephalopathy (PSE), quality of life, and direct costs of care. In the RCT of ET versus PCS, 28 and 30%, respectively, were in Child class C. In the expanded RCT of TIPS versus EPCS, 40 and 41%, respectively, were in Child class C. Permanent control of BGV was achieved in 97-100% of patients treated by emergency or elective PCS, compared with 27-29% by ET. TIPS was even less effective, achieving long-term control of BGV in only 6%. Survival rates after PCS were greater at all time intervals and in all Child classes (P < .001). Repeated episodes of PSE occurred in 50% of TIPS patients, 16-17% treated by ET, and 8-11% treated by PCS. Shunt stenosis or occlusion occurred in 67% of TIPS patients, in contrast with 0-2% of PCS patients.
CONCLUSION
These results support the conclusion that PCS is uniformly effective, whereas ET and TIPS are not very effective.
重要性
食管静脉曲张出血已得到广泛研究，但胃静脉曲张出血（BGV）的研究要少得多。然而，据报道，在急性静脉曲张出血患者中，BGV的发生率≤30%。在我们对1836例出血性肝硬化患者的研究中，12.7%的患者为胃静脉曲张出血。据报道，BGV的死亡率为45% - 55%。关于BGV的文献主要是回顾性病例报告，随访时间往往较短。
目的
我们试图描述一项前瞻性、随机、对照试验（RCT）的结果，该试验针对未经选择的连续性BGV患者，比较内镜治疗（ET）与门腔分流术（PCS；n = 518），随后比较急诊经颈静脉肝内门体分流术（TIPS）与急诊门腔分流术（EPCS；n = 70）。
设计、背景和参与者：最初，我们的RCT纳入了518例BGV患者，比较ET与直接PCS在控制出血、死亡率和残疾方面的效果。当患者入组结束时，RCT扩展为比较急诊TIPS与EPCS（n = 70）。这项BGV的RCT与我们其他关于食管静脉曲张出血的RCT是分开的。
干预措施
最初，比较ET与PCS。在RCT的第二部分，比较急诊TIPS与急诊PCS（EPCS）。
主要观察指标
观察指标包括生存率、出血控制情况、门体性脑病（PSE）、生活质量和直接护理成本。在ET与PCS的RCT中，分别有28%和30%的患者为Child C级。在扩展的TIPS与EPCS的RCT中，分别有40%和41%的患者为Child C级。急诊或择期PCS治疗的患者中，97% - 100%实现了BGV的永久控制，而ET治疗的患者这一比例为27% - 29%。TIPS的效果更差，仅6%的患者实现了BGV的长期控制。PCS后的各时间段生存率及所有Child分级患者的生存率均更高（P < 0.001）。50%的TIPS患者出现PSE复发，ET治疗的患者中这一比例为16% - 17%，PCS治疗的患者中为8% - 11%。67%的TIPS患者出现分流狭窄或闭塞，而PCS患者中这一比例为0 - 2%。
结论
这些结果支持以下结论，即PCS始终有效，而ET和TIPS效果不佳。
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