Biffi R, Orsi F, Pozzi S, Pace U, Bonomo G, Monfardini L, Della Vigna P, Rotmensz N, Radice D, Zampino M G, Fazio N, de Braud F, Andreoni B, Goldhirsch A
Division of Abdomino-Pelvic Surgery, European Institute of Oncology, via Ripamonti 435, I-20141 Milan, Italy.
Ann Oncol. 2009 May;20(5):935-40. doi: 10.1093/annonc/mdn701. Epub 2009 Jan 29.
Central venous access is extensively used in oncology, though practical information from randomized trials on the most convenient insertion modality and site is unavailable.
Four hundred and three patients eligible for receiving i.v. chemotherapy for solid tumors were randomly assigned to implantation of a single type of port (Bard Port, Bard Inc., Salt Lake City, UT), through a percutaneous landmark access to the internal jugular, a ultrasound (US)-guided access to the subclavian or a surgical cut-down access through the cephalic vein at the deltoid-pectoralis groove. Early and late complications were prospectively recorded until removal of the device, patient's death or ending of the study.
Four hundred and one patients (99.9%) were assessable: 132 with the internal jugular, 136 with the subclavian and 133 with the cephalic vein access. The median follow-up was 356.5 days (range 0-1087). No differences were found for early complication rate in the three groups {internal jugular: 0% [95% confidence interval (CI) 0.0% to 2.7%], subclavian: 0% (95% CI 0.0% to 2.7%), cephalic: 1.5% (95% CI 0.1% to 5.3%)}. US-guided subclavian insertion site had significantly lower failures (e.g. failed attempts to place the catheter in agreement with the original arm of randomization, P = 0.001). Infections occurred in one, three and one patients (internal jugular, subclavian and cephalic access, respectively, P = 0.464), whereas venous thrombosis was observed in 15, 8 and 11 patients (P = 0.272).
Central venous insertion modality and sites had no impact on either early or late complication rates, but US-guided subclavian insertion showed the lowest proportion of failures.
中心静脉通路在肿瘤学中被广泛应用,然而关于最便捷的置入方式和部位的随机试验的实用信息尚不可得。
403例符合接受实体瘤静脉化疗条件的患者被随机分配,通过经皮体表定位进入颈内静脉、超声引导进入锁骨下静脉或在三角肌胸大肌沟处经头静脉进行外科切开的方式,植入单一类型的端口(巴德端口,巴德公司,盐湖城,犹他州)。前瞻性记录早期和晚期并发症,直至装置移除、患者死亡或研究结束。
401例患者(99.9%)可进行评估:132例经颈内静脉、136例经锁骨下静脉、133例经头静脉通路。中位随访时间为356.5天(范围0 - 1087天)。三组的早期并发症发生率无差异{颈内静脉:0%[95%置信区间(CI)0.0%至2.7%],锁骨下静脉:0%(95%CI 0.0%至2.7%),头静脉:1.5%(95%CI 0.1%至5.3%)}。超声引导的锁骨下置入部位的失败率显著更低(例如,与随机分组的原方案不一致的置管失败尝试,P = 0.001)。感染分别发生在1例、3例和1例患者中(颈内静脉、锁骨下静脉和头静脉通路,P = 0.464),而静脉血栓形成分别在15例、8例和11例患者中观察到(P = 0.272)。
中心静脉置入方式和部位对早期或晚期并发症发生率均无影响,但超声引导的锁骨下置入失败率最低。