Zorrón Pu Leonardo, de Moura Eduardo Guimarães Hourneaux, Bernardo Wanderley Marques, Baracat Felipe Iankelevich, Mendonça Ernesto Quaresma, Kondo André, Luz Gustavo Oliveira, Furuya Júnior Carlos Kiyoshi, Artifon Everson Luiz de Almeida
Leonardo Zorrón Pu, Eduardo Guimarães Hourneaux de Moura, Felipe Iankelevich Baracat, Ernesto Quaresma Mendonça, André Kondo, Gustavo Oliveira Luz, Carlos Kiyoshi Furuya Júnior, Everson Luiz de Almeida Artifon, Gastrointestinal Endoscopy Division, Department of Gastroenterology, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Sao Paulo 05403-000, Brazil.
World J Gastroenterol. 2015 Dec 21;21(47):13374-85. doi: 10.3748/wjg.v21.i47.13374.
To analyze through meta-analyses the benefits of two types of stents in the inoperable malignant biliary obstruction.
A systematic review of randomized clinical trials (RCT) was conducted, with the last update on March 2015, using EMBASE, CINAHL (EBSCO), MEDLINE, LILACS/CENTRAL (BVS), SCOPUS, CAPES (Brazil), and gray literature. Information of the selected studies was extracted in sight of six outcomes: primarily regarding dysfunction, complication and re-intervention rates; and secondarily costs, survival, and patency time. The data about characteristics of trial participants, inclusion and exclusion criteria and types of stents were also extracted. The bias was mainly assessed through the JADAD scale. This meta-analysis was registered in the PROSPERO database by the number CRD42014015078. The analysis of the absolute risk of the outcomes was performed using the software RevMan, by computing risk differences (RD) of dichotomous variables and mean differences (MD) of continuous variables. Data on RD and MD for each primary outcome were calculated using the Mantel-Haenszel test and inconsistency was qualified and reported in χ (2) and the Higgins method (I (2)). Sensitivity analysis was performed when heterogeneity was higher than 50%, a subsequent assay was done and other findings were compiled. Student's t-test was used for the comparison of weighted arithmetic means regarding secondary outcomes.
Initial searching identified 3660 studies; 3539 were excluded through title, repetition, and/or abstract, while 121 studies were fully assessed and were excluded mainly because they did not compare self-expanding metal stents (SEMS) and plastic stents (PS), leading to thirteen RCT selected, with 13 articles and 1133 subjects meta-analyzed. The mean age was 69.5 years old, that were affected mostly by bile duct (proximal) and pancreatic tumors (distal). The preferred SEMS diameter used was the 10 mm (30 Fr) and the preferred PS diameter used was 10 Fr. In the meta-analysis, SEMS had lower overall stent dysfunction compared to PS (21.6% vs 46.8%, P < 0.00001) and fewer re-interventions (21.6% vs 56.6%, P < 0.00001), with no difference in complications (13.7% vs 15.9%, P = 0.16). In the secondary analysis, the mean survival rate was higher in the SEMS group (182 d vs 150 d, P < 0.0001), with a higher patency period (250 d vs 124 d, P < 0.0001) and a lower cost per patient (4193.98 vs 4728.65 Euros, P < 0.0985).
SEMS are associated with lower stent dysfunction, lower re-intervention rates, better survival, and higher patency time. Complications and costs showed no difference.
通过荟萃分析来剖析两种类型的支架在不可手术切除的恶性胆管梗阻中的益处。
对随机临床试验（RCT）进行系统评价，截至2015年3月的最新数据，使用EMBASE、CINAHL（EBSCO）、MEDLINE、LILACS/CENTRAL（BVS）、SCOPUS、CAPES（巴西）以及灰色文献。从六个结果方面提取所选研究的信息：主要涉及功能障碍、并发症和再次干预率；其次是成本、生存率和通畅时间。还提取了关于试验参与者特征、纳入和排除标准以及支架类型的数据。主要通过JADAD量表评估偏倚。该荟萃分析已在PROSPERO数据库中注册，注册号为CRD42014015078。使用RevMan软件对结果的绝对风险进行分析，通过计算二分变量的风险差异（RD）和连续变量的均值差异（MD）。每个主要结果的RD和MD数据使用Mantel-Haenszel检验计算，不一致性通过χ²和Higgins方法（I²）进行量化和报告。当异质性高于50%时进行敏感性分析，随后进行后续分析并汇总其他结果。采用学生t检验比较次要结果的加权算术平均值。
初步检索确定了3660项研究；通过标题、重复和/或摘要排除了3539项，对121项研究进行了全面评估，主要因未比较自膨式金属支架（SEMS）和塑料支架（PS）而被排除，最终选择了13项RCT，对13篇文章和1133名受试者进行荟萃分析。平均年龄为69.5岁，主要受胆管（近端）和胰腺肿瘤（远端）影响。使用的SEMS首选直径为10mm（30Fr），PS首选直径为10Fr。在荟萃分析中，与PS相比，SEMS的总体支架功能障碍更低（21.6%对46.8%，P<0.00001），再次干预更少（21.6%对56.6%，P<0.00001），并发症无差异（13.7%对15.9%，P=0.16）。在次要分析中，SEMS组的平均生存率更高（182天对150天，P<0.0001），通畅期更长（250天对124天，P<0.0001），每位患者的成本更低（4193.98对4728.65欧元，P<0.0985）。
SEMS与更低的支架功能障碍、更低的再次干预率、更好的生存率和更长的通畅时间相关。并发症和成本无差异。
