Ede Chikwendu J, Nikolova Dimitrinka, Brand Martin
Department of Surgery, University of the Witwatersrand, 7 York Road, Johannesburg, Gauteng, South Africa, 2193.
Cochrane Database Syst Rev. 2018 Aug 3;8(8):CD011717. doi: 10.1002/14651858.CD011717.pub2.
Hepatosplenic schistosomiasis is an important cause of variceal bleeding in low-income countries. Randomised clinical trials have evaluated the outcomes of two categories of surgical interventions, shunts and devascularisation procedures, for the prevention of variceal rebleeding in people with hepatosplenic schistosomiasis. The comparative overall benefits and harms of these two interventions are unclear.
To assess the benefits and harms of surgical portosystemic shunts versus oesophagogastric devascularisation procedures for the prevention of variceal rebleeding in people with hepatosplenic schistosomiasis.
We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE, Embase, Science Citation Index Expanded, LILACS, reference lists of articles, and proceedings of relevant associations for trials that met the inclusion criteria (date of search 11 January 2018).
Randomised clinical trials comparing surgical portosystemic shunts versus oesophagogastric devascularisation procedures for the prevention of variceal rebleeding in people with hepatosplenic schistosomiasis.
Two review authors independently assessed the trials and extracted data using methodological standards expected by Cochrane. We assessed risk of bias according to domains and risk of random errors with GRADE and Trial Sequential Analysis. We assessed the certainty of evidence using the GRADE approach.
We found two randomised clinical trials including 154 adult participants, aged between 18 years and 65 years, diagnosed with hepatosplenic schistosomiasis. One of the trials randomised participants to proximal splenorenal shunt versus distal splenorenal shunt versus oesophagogastric devascularisation with splenectomy, and the other randomised participants to distal splenorenal shunt versus oesophagogastric devascularisation with splenectomy. In both trials the diagnosis of hepatosplenic schistosomiasis was made based on clinical and biochemical assessments. The trials were conducted in Brazil and Egypt. Both trials were at high risk of bias.We are uncertain as to whether surgical portosystemic shunts improved all-cause mortality compared with oesophagogastric devascularisation with splenectomy due to imprecision in the trials (risk ratio (RR) 2.35, 95% confidence interval (CI) 0.55 to 9.92; participants = 154; studies = 2). We are uncertain whether serious adverse events differed between surgical portosystemic shunts and oesophagogastric devascularisation with splenectomy (RR 2.26, 95% CI 0.44 to 11.70; participants = 154; studies = 2). None of the trials reported on health-related quality of life. We are uncertain whether variceal rebleeding differed between surgical portosystemic shunts and oesophagogastric devascularisation with splenectomy (RR 0.39, 95% CI 0.13 to 1.23; participants = 154; studies = 2). We found evidence suggesting an increase in encephalopathy in the shunts group versus the devascularisation with splenectomy group (RR 7.51, 95% CI 1.45 to 38.89; participants = 154; studies = 2). We are uncertain whether ascites and re-interventions differed between surgical portosystemic shunts and oesophagogastric devascularisation with splenectomy. We computed Trial Sequential Analysis for all outcomes, but the trial sequential monitoring boundaries could not be drawn because of insufficient sample size and events. We downgraded the overall certainty of the body of evidence for all outcomes to very low due to risk of bias and imprecision.
AUTHORS' CONCLUSIONS: Given the very low certainty of the available body of evidence and the low number of clinical trials, we could not determine an overall benefit or harm of surgical portosystemic shunts compared with oesophagogastric devascularisation with splenectomy. Future randomised clinical trials should be designed with sufficient statistical power to assess the benefits and harms of surgical portosystemic shunts versus oesophagogastric devascularisations with or without splenectomy and with or without oesophageal transection.
肝脾血吸虫病是低收入国家门静脉高压出血的重要原因。随机临床试验评估了两类手术干预措施(分流术和断流术)对预防肝脾血吸虫病患者门静脉高压再出血的效果。这两种干预措施的总体利弊尚不清楚。
评估手术门体分流术与食管胃断流术预防肝脾血吸虫病患者门静脉高压再出血的利弊。
我们检索了Cochrane肝胆组对照试验注册库、Cochrane系统评价数据库、医学期刊数据库、Embase数据库、科学引文索引扩展版、拉丁美洲及加勒比地区卫生科学数据库、文章参考文献列表以及相关协会的会议记录,以查找符合纳入标准的试验(检索日期为2018年1月11日)。
比较手术门体分流术与食管胃断流术预防肝脾血吸虫病患者门静脉高压再出血的随机临床试验。
两位综述作者独立评估试验并按照Cochrane预期的方法标准提取数据。我们根据不同领域评估偏倚风险,并使用GRADE和试验序贯分析评估随机误差风险。我们采用GRADE方法评估证据的确定性。
我们发现两项随机临床试验,共纳入154名年龄在18岁至65岁之间、被诊断为肝脾血吸虫病的成年参与者。其中一项试验将参与者随机分为近端脾肾分流术组、远端脾肾分流术组和食管胃断流术加脾切除术组,另一项试验将参与者随机分为远端脾肾分流术组和食管胃断流术加脾切除术组。两项试验均根据临床和生化评估诊断肝脾血吸虫病。试验在巴西和埃及进行。两项试验均存在较高的偏倚风险。由于试验结果不精确,我们不确定手术门体分流术与食管胃断流术加脾切除术相比是否能改善全因死亡率(风险比(RR)2.35,95%置信区间(CI)0.55至9.92;参与者 = 154;研究 = 2)。我们不确定手术门体分流术与食管胃断流术加脾切除术相比严重不良事件是否存在差异(RR 2.26,95% CI 0.44至11.70;参与者 = 154;研究 = 2)。没有试验报告与健康相关的生活质量。我们不确定手术门体分流术与食管胃断流术加脾切除术相比门静脉高压再出血是否存在差异(RR = 0.39,95% CI 0.13至1.23;参与者 = 154;研究 = 2)。我们发现有证据表明分流术组与断流术加脾切除术组相比脑病发生率增加(RR 7.51,95% CI 1.45至38.89;参与者 = 154;研究 = 2)。我们不确定手术门体分流术与食管胃断流术加脾切除术相比腹水和再次干预是否存在差异。我们对所有结局进行了试验序贯分析,但由于样本量和事件数量不足,无法绘制试验序贯监测边界。由于存在偏倚风险和不精确性,我们将所有结局证据体的总体确定性降至极低。
鉴于现有证据体的确定性极低且临床试验数量较少,我们无法确定手术门体分流术与食管胃断流术加脾切除术相比的总体利弊。未来的随机临床试验应设计足够的统计效能,以评估手术门体分流术与食管胃断流术(无论是否行脾切除术以及是否行食管横断术)的利弊。