Department of Surgery, University of California-San Diego Medical Center, 200 West Arbor Drive, San Diego, CA 92103-8999, USA.
J Gastrointest Surg. 2012 Nov;16(11):2094-111. doi: 10.1007/s11605-012-2003-6. Epub 2012 Sep 25.
Emergency treatment of bleeding esophageal varices (BEV) in cirrhosis is of paramount importance because of the resultant high mortality rate. Emergency therapy today consists mainly of endoscopic and pharmacologic measures, with use of transjugular intrahepatic portosystemic shunt (TIPS) when bleeding is not controlled. Surgical portosystemic shunt has been relegated to last resort salvage when all other measures fail. Regrettably, no randomized controlled trials have been reported in which TIPS and surgical portosystemic shunt were compared in unselected patients with acute BEV, with long-term follow-up. This is a report of a long-term prospective randomized controlled trial (RCT) that compared TIPS with emergency portacaval shunt (EPCS) in patients with cirrhosis and acute BEV.
A total of 154 unselected, consecutive cirrhotic patients ("all comers") with acute BEV were randomized to TIPS (n = 78) or EPCS (n = 76), and the two treatments were compared with regard to effect on survival, control of bleeding, portal-systemic encephalopathy (PSE), and disability. Diagnostic workup was completed within 6 h and TIPS or EPCS was initiated within 24 h. Regular follow-up was accomplished in 100 % of patients and lasted for 5 to 10 years in 85 % and 3 to 4.5 years in the remainder. This report focuses on control of bleeding and survival.
The clinical characteristics of the two groups were similar, and the distribution of Child classes A, B, and C was almost identical. TIPS was successful in controlling BEV for 30 days in 80 % of patients but achieved long-term control of BEV in only 22 %. In contrast, EPCS controlled BEV immediately in all patients and permanently in 97 % (p < 0.001). TIPS patients required almost twice as many units of blood transfusion as EPCS patients. Survival rate at all time intervals and in all Child classes was significantly greater following EPCS than after TIPS (p < 0.001). Median survival was over 10 years following EPCS, compared to 1.99 years following TIPS. Stenosis or occlusion of TIPS was demonstrated in 84 % of patients who survived 21 days, 63 % of whom underwent TIPS revision, which failed in 80 %. In contrast, EPCS remained permanently patent in 97 % of patients. Recurrent PSE was threefold more frequent following TIPS than after EPCS (61 versus 21 %).
EPCS was uniformly effective in the treatment of BEV, while TIPS was disappointing. EPCS accomplished long-term survival while TIPS resulted in a survival rate that was less than one fifth that of EPCS. The results of this RCT in unselected, consecutive patients justify the use of EPCS as a first-line emergency treatment of BEV in cirrhosis (clinicaltrials.gov #NCT00734227).
肝硬化食管静脉曲张（BEV）出血的紧急治疗至关重要，因为其死亡率很高。目前的紧急治疗主要包括内镜和药物治疗，如果出血无法控制，则使用经颈静脉肝内门体分流术（TIPS）。当所有其他措施都失败时，外科门体分流术被降级为最后的抢救手段。遗憾的是，没有报道过将 TIPS 和外科门体分流术在未经选择的急性 BEV 患者中进行比较的随机对照试验（RCT），并进行长期随访。这是一项报告了一项长期前瞻性随机对照试验（RCT）的研究，该研究比较了 TIPS 和紧急门腔分流术（EPCS）在肝硬化和急性 BEV 患者中的疗效。
共有 154 名未经选择的连续肝硬化患者（“所有患者”）出现急性 BEV，被随机分为 TIPS（n=78）或 EPCS（n=76）组，比较两种治疗方法对生存率、出血控制、门脉系统脑病（PSE）和残疾的影响。诊断性检查在 6 小时内完成，TIPS 或 EPCS 在 24 小时内开始。100%的患者进行了定期随访，85%的患者随访时间为 5 至 10 年，其余患者随访时间为 3 至 4.5 年。本报告重点关注出血控制和生存率。
两组的临床特征相似，Child 分级 A、B 和 C 的分布几乎相同。TIPS 在 80%的患者中成功地在 30 天内控制了 BEV，但仅在 22%的患者中实现了长期控制。相比之下，EPCS 立即在所有患者中控制了 BEV，永久性控制率为 97%（p<0.001）。TIPS 患者所需的输血单位几乎是 EPCS 患者的两倍。在所有时间间隔和所有 Child 分级中，EPCS 后的生存率明显高于 TIPS（p<0.001）。EPCS 后的中位生存时间超过 10 年，而 TIPS 后为 1.99 年。在存活 21 天的患者中，有 84%的患者出现 TIPS 狭窄或闭塞，其中 63%接受了 TIPS 修复，但 80%的修复失败。相比之下，EPCS 在 97%的患者中保持永久性通畅。TIPS 后复发性 PSE 的发生率是 EPCS 后的三倍（61 比 21%）。
EPCS 治疗 BEV 效果一致，而 TIPS 则令人失望。EPCS 实现了长期生存，而 TIPS 的生存率不到 EPCS 的五分之一。这项在未经选择的连续患者中进行的 RCT 结果证明，EPCS 可作为肝硬化 BEV 的一线紧急治疗方法（clinicaltrials.gov #NCT00734227）。
