Department of Nephrology, Ruijin Hospital, Shanghai Jiaotong University, School of Medicine, Shanghai, China.
Am J Kidney Dis. 2011 Dec;58(6):946-55. doi: 10.1053/j.ajkd.2011.06.026. Epub 2011 Aug 27.
Variations in peritoneal dialysis catheter design include differences in numbers of cuffs, shapes of subcutaneous paths (swan neck vs Tenckhoff), and shapes of intra-abdominal segments (straight vs coiled). The relative benefits of these designs have not been studied adequately. The objective of this study is to compare the clinical outcomes of coiled- versus straight-end swan neck peritoneal dialysis catheters.
Prospective randomized controlled trial (RCT); results were meta-analyzed with other RCTs of coiled versus straight catheters.
SETTING & PARTICIPANTS: 80 consecutive continuous ambulatory peritoneal dialysis patients were enrolled in the RCT. The meta-analysis considers data for 242 patients with coiled and 251 patients with straight catheters.
Patients were randomly assigned to a coiled-end swan neck catheter (n = 40) or a straight-end swan neck catheter (n = 40) group.
Catheter tip migration with dysfunction (primary outcome) and catheter failure, catheter-related infection, technique failure, and all-cause mortality (secondary outcomes).
The primary outcome occurred in 18 patients in the coiled group and 9 in the straight group. This difference was not statistically significant (HR, 1.96; 95% CI, 0.88-4.37; P = 0.09). Although rates of early (<8 weeks) catheter tip migration were similar between the 2 groups, we detected a significant association of the coiled design with increased risk of late (>8 weeks) catheter tip migration (HR, 6.43; 95% CI, 1.45-28.6; P = 0.005). The increased risk of overall catheter failure in the coiled group was not statistically significant (P = 0.06). In the meta-analysis, coiled catheters were associated significantly with increased risk of catheter tip migration (based on 4 trials: RR, 2.08; 95% CI, 1.30-3.33; P = 0.002).
Single-center open-label experimental study powered to detect differences in only the most common complication of catheter tip migration with dysfunction. Our RCT examines only swan neck catheters, whereas the meta-analysis considers both swan neck and Tenckhoff designs.
Although we were unable to show statistically significant differences in the primary outcome in our RCT, pooled meta-analysis results suggest that coiled catheters may be more prone to migration and resultant dysfunction.
腹膜透析导管的设计差异包括袖口数量、皮下路径形状（鹅颈型与 Tenckhoff 型）和腹腔内段形状（直型与螺旋型）的不同。这些设计的相对优势尚未得到充分研究。本研究旨在比较螺旋型与直型鹅颈腹膜透析导管的临床结局。
前瞻性随机对照试验（RCT）；对螺旋型与直型导管的其他 RCT 进行了荟萃分析。
连续纳入 80 例接受持续非卧床腹膜透析的患者参与 RCT。荟萃分析纳入了 242 例螺旋型导管和 251 例直型导管患者的数据。
患者被随机分配至螺旋型鹅颈导管（n = 40）或直型鹅颈导管（n = 40）组。
导管尖端迁移伴功能障碍（主要结局）以及导管故障、导管相关性感染、技术失败和全因死亡率（次要结局）。
螺旋型组有 18 例患者和直型组有 9 例患者发生主要结局。差异无统计学意义（HR，1.96；95%CI，0.88-4.37；P = 0.09）。尽管两组早期（＜8 周）导管尖端迁移率相似，但我们发现螺旋型设计与晚期（＞8 周）导管尖端迁移风险增加显著相关（HR，6.43；95%CI，1.45-28.6；P = 0.005）。螺旋型组的总体导管故障风险增加无统计学意义（P = 0.06）。荟萃分析显示，螺旋型导管与导管尖端迁移风险增加显著相关（基于 4 项试验：RR，2.08；95%CI，1.30-3.33；P = 0.002）。
单中心开放标签实验研究旨在检测导管尖端迁移伴功能障碍这一最常见并发症的差异，但本研究未检测到统计学差异。本 RCT 仅检查鹅颈型导管，而荟萃分析则考虑了鹅颈型和 Tenckhoff 型设计。
尽管我们未能在 RCT 中显示出统计学显著的主要结局差异，但汇总的荟萃分析结果表明，螺旋型导管更可能发生迁移并导致功能障碍。
