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用于植入完全植入式静脉通路端口的静脉切开术与塞丁格技术的比较

Venous cutdown versus the Seldinger technique for placement of totally implantable venous access ports.

作者信息

Hsu Charlie C-T, Kwan Gigi N C, Evans-Barns Hannah, Rophael John A, van Driel Mieke L

机构信息

Department of Medical Imaging, Princess Alexandra Hospital, 199 Ipswich Road, Brisbane, Queensland, Australia, 4102.

出版信息

Cochrane Database Syst Rev. 2016 Aug 21;2016(8):CD008942. doi: 10.1002/14651858.CD008942.pub2.

Abstract

BACKGROUND

Totally implantable venous access ports (TIVAPs) provide patients with a safe and permanent venous access, for instance in the administration of chemotherapy for oncology patients. There are several methods for TIVAP placement, and the optimal evidence-based method is unclear.

OBJECTIVES

To compare the efficacy and safety of three commonly used techniques for implanting TIVAPs: the venous cutdown technique, the Seldinger technique, and the modified Seldinger technique. This review includes studies that use Doppler or real-time two-dimensional ultrasonography for locating the vein in the Seldinger technique.

SEARCH METHODS

The Cochrane Vascular Trials Search Co-ordinator searched the Cochrane Vascular Specialised Register (last searched August 2015) and the Cochrane Central Register of Controlled Trials (CENTRAL) (2015, Issue 7), as well as clinical trials registers.

SELECTION CRITERIA

We included randomised or quasi-randomised controlled clinical trials that randomly allocated people requiring TIVAP to the venous cutdown, Seldinger, or modified Seldinger technique. Two review authors independently assessed studies for inclusion eligibility, with a third review author checking excluded studies.

DATA COLLECTION AND ANALYSIS

Two review authors independently extracted data. We assessed all studies for risk of bias. We assessed heterogeneity using Chi(2) statistic and variance (I(2)statistic) methods. Dichotomous outcomes, summarised as odds ratio (OR) with 95% confidence interval (CI), were: primary implantation success, complications (in particular infection), pneumothorax, and catheter complications. We conducted separate analyses to assess the two access veins, subclavian and internal jugular (IJ) vein, in the Seldinger technique versus the venous cutdown technique. We used both intention-to-treat (ITT) and on-treatment analyses and pooled data using a fixed-effect model.

MAIN RESULTS

We included nine studies with a total of 1253 participants in the review. Five studies compared Seldinger technique (subclavian vein access) with venous cutdown technique (cephalic vein access). Two studies compared Seldinger (IJ vein) versus venous cutdown (cephalic vein). One study compared the modified Seldinger technique (cephalic vein) with the venous cutdown (cephalic vein), and one study compared the Seldinger (subclavian vein) versus the Seldinger (IJ vein) technique.Seldinger technique (subclavian or IJ vein access) versus venous cutdown (cephalic vein): We included seven trials with 1006 participants for analysis. Both ITT (OR 0.40; 95% CI 0.25 to 0.65) and on-treatment analysis (OR 0.59; 95% CI 0.36 to 0.98) showed that the Seldinger technique for implantation of TIVAP had a higher success rate compared with the venous cutdown technique. We found no difference between overall peri- and postoperative complication rates: ITT (OR 1.16; 95% CI 0.76 to 1.75) and on-treatment analysis (OR 0.93; 95% CI 0.62 to 1.40). In the Seldinger group, the majority of the trials reported use of the subclavian vein for venous access, with only a limited number of trials utilising the IJ vein for access. When individual complication rates of infection, pneumothorax, and catheter complications were analysed, the Seldinger technique (subclavian vein access) was associated with a higher rate of catheter complications compared to the venous cutdown technique: ITT (OR 6.77; 95% CI 2.31 to 19.79) and on-treatment analysis (OR 6.62; 95% CI 2.24 to 19.58). There was no difference in incidence of infections, pneumothorax, and other complications between the groups.Modified Seldinger technique (cephalic vein) versus venous cutdown (cephalic vein): We identified one trial with 164 participants. ITT analysis showed no difference in primary implantation success rate between the modified Seldinger technique (69/82, 84%) and the venous cutdown technique (66/82, 80%), P = 0.686. We observed no differences in the peri- or postoperative complication rates.Seldinger (subclavian vein access) versus Seldinger (IJ vein access): We identified one trial with 83 participants. The primary success rate was 84% (37/44) for Seldinger (subclavian vein) versus 74% (29/39) for the Seldinger (IJ vein). There was a higher overall complication rate in the subclavian group (48%) compared to the jugular group (23%), P = 0.02. However, when specific complications were compared individually, we found no differences between the groups.The overall quality of the trials included in this review was moderate. The methods used for randomisation were inadequate in four of the nine included studies, but sensitivity analysis excluding these trials did not alter the outcome. The nature of the interventions, either venous cutdown or Seldinger techniques, meant that it was not feasible to blind the participant or personnel, therefore we judged this to be at low risk of bias. The majority of participants in the included trials were oncology patients at tertiary centres, and the outcomes were applicable to the typical clinical scenario. For all outcomes, when comparing venous cutdown and Seldinger technique, serious imprecision was evident by wide confidence intervals in the included trials. The quality of the overall evidence was therefore downgraded from high to moderate. Due to the limited number of included studies we were unable to assess publication bias.

AUTHORS' CONCLUSIONS: Moderate-quality evidence showed that the Seldinger technique has a higher primary implantation success rate compared with the venous cutdown technique. The majority of trials using the Seldinger technique used the subclavian vein for venous access, and only a few trials reported the use of the internal jugular vein for venous access. Moderate-quality evidence showed no difference in the overall complication rate between the Seldinger and venous cutdown techniques. However, when the Seldinger technique with subclavian vein access was compared with the venous cutdown group, there was a higher reported incidence of catheter complications. The rates of pneumothorax and infection did not differ between the Seldinger and venous cutdown group. We identified only one trial for each of the comparisons modified Seldinger technique (cephalic vein) versus venous cutdown (cephalic vein) and Seldinger (subclavian vein access) versus Seldinger (IJ vein access), thus a definitive conclusion cannot be drawn for these comparisons and further research is recommended.

摘要

背景

全植入式静脉通路端口(TIVAPs)为患者提供了一种安全且永久性的静脉通路,例如用于肿瘤患者的化疗给药。TIVAP放置有多种方法,而最佳的循证方法尚不清楚。

目的

比较三种常用的TIVAP植入技术的疗效和安全性:静脉切开技术、Seldinger技术和改良Seldinger技术。本综述纳入了在Seldinger技术中使用多普勒或实时二维超声定位静脉的研究。

检索方法

Cochrane血管试验搜索协调员检索了Cochrane血管专业注册库(最后检索时间为2015年8月)、Cochrane对照试验中央注册库(CENTRAL)(2015年第7期)以及临床试验注册库。

选择标准

我们纳入了随机或半随机对照临床试验,这些试验将需要TIVAP的患者随机分配至静脉切开、Seldinger或改良Seldinger技术组。两位综述作者独立评估研究的纳入资格,第三位综述作者检查排除的研究。

数据收集与分析

两位综述作者独立提取数据。我们评估了所有研究的偏倚风险。我们使用卡方统计量和方差(I²统计量)方法评估异质性。二分结局总结为比值比(OR)及95%置信区间(CI),包括:初次植入成功率、并发症(尤其是感染)、气胸和导管相关并发症。我们进行了单独分析,以评估Seldinger技术与静脉切开技术中两条穿刺静脉,即锁骨下静脉和颈内静脉(IJ)的情况。我们使用意向性分析(ITT)和实际治疗分析,并采用固定效应模型合并数据。

主要结果

我们纳入了9项研究,共1253名参与者。5项研究比较了Seldinger技术(锁骨下静脉穿刺)与静脉切开技术(头静脉穿刺)。2项研究比较了Seldinger技术(IJ静脉)与静脉切开技术(头静脉)。1项研究比较了改良Seldinger技术(头静脉)与静脉切开技术(头静脉),1项研究比较了Seldinger技术(锁骨下静脉)与Seldinger技术(IJ静脉)。

Seldinger技术(锁骨下或IJ静脉穿刺)与静脉切开技术(头静脉穿刺):我们纳入了7项试验,共1006名参与者进行分析。ITT分析(OR 0.40;95% CI 0.25至0.65)和实际治疗分析(OR 0.59;95% CI 0.36至0.98)均显示,TIVAP植入的Seldinger技术成功率高于静脉切开技术。我们发现总体围手术期和术后并发症发生率无差异:ITT分析(OR 1.16;95% CI 0.76至1.75)和实际治疗分析(OR 0.93;95% CI 0.62至1.40)。在Seldinger组中,大多数试验报告使用锁骨下静脉进行静脉穿刺通路,只有少数试验使用IJ静脉进行穿刺。当分析感染、气胸和导管相关并发症的个体发生率时,与静脉切开技术相比,Seldinger技术(锁骨下静脉穿刺)的导管相关并发症发生率更高:ITT分析(OR 6.77;95% CI 2.31至19.79)和实际治疗分析(OR 6.62;95% CI至19.58)。两组间感染、气胸和其他并发症的发生率无差异。

改良Seldinger技术(头静脉)与静脉切开技术(头静脉):我们纳入了1项试验,共164名参与者。ITT分析显示,改良Seldinger技术(69/82,84%)与静脉切开技术(66/82,80%)的初次植入成功率无差异,P = 0.686。我们未观察到围手术期或术后并发症发生率的差异。

Seldinger技术(锁骨下静脉穿刺)与Seldinger技术(IJ静脉穿刺):我们纳入了1项试验,共83名参与者。Seldinger技术(锁骨下静脉)的初次成功率为84%(37/44),而Seldinger技术(IJ静脉)为74%(29/39)。锁骨下组的总体并发症发生率(48%)高于颈静脉组(23%),P = 0.02。然而,当单独比较特定并发症时,我们发现两组间无差异。

本综述纳入试验的总体质量为中等。9项纳入研究中有4项的随机化方法不充分,但排除这些试验的敏感性分析并未改变结果。干预措施的性质,无论是静脉切开还是Seldinger技术,意味着对参与者或人员进行盲法不可行,因此我们认为这方面的偏倚风险较低。纳入试验中的大多数参与者是三级中心的肿瘤患者,结果适用于典型临床场景。对于所有结局,在比较静脉切开和Seldinger技术时,纳入试验的宽置信区间显示存在明显的严重不精确性。因此,总体证据质量从高等级降至中等等级。由于纳入研究数量有限,我们无法评估发表偏倚。

作者结论

中等质量证据表明,与静脉切开技术相比,Seldinger技术的初次植入成功率更高。大多数使用Seldinger技术的试验采用锁骨下静脉进行静脉穿刺通路,只有少数试验报告使用颈内静脉进行静脉穿刺通路。中等质量证据表明,Seldinger技术与静脉切开技术的总体并发症发生率无差异。然而,当将锁骨下静脉穿刺的Seldinger技术与静脉切开组进行比较时,报告的导管相关并发症发生率较高。Seldinger组和静脉切开组的气胸和感染发生率无差异。对于改良Seldinger技术(头静脉)与静脉切开技术(头静脉)以及Seldinger技术(锁骨下静脉穿刺)与Seldinger技术(IJ静脉穿刺)的每项比较,我们仅纳入了1项试验,因此无法对这些比较得出明确结论,建议进一步研究。

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