Bacchetti Stefano, Pasqual Enricomaria, Crozzolo Elena, Pellarin Alessandra, Cagol Pier Paolo
Department of Surgical Sciences, Faculty of Medicine and Surgery, University of Udine, Italy.
Med Devices (Auckl). 2009;2:31-40. doi: 10.2147/mder.s4036. Epub 2009 Mar 16.
Hepatic artery infusion (HAI) is indicated to treat unresectable colorectal hepatic metastases, with recent applications as a neoadjuvant or adjuvant treatment. Traditionally performed with the infusion of fluoropyrimidine-based chemotherapy, it has been now tested with oxaliplatin or irinotecan and associated with systemic chemotherapy.
To evaluate the impact of medical devices complications we carried out a search of the published studies on HAI in unresectable colorectal liver metastases. Complications were pooled according to the applied medical system: 1) surgical catheter, 2) radiological catheter, and 3) fully implantable pump. The surgical catheter is inserted into the hepatic artery from the gastro-duodenal artery. The radiological catheter is inserted into the hepatic artery through a percutaneous transfemoral or transaxillar access. The fully implantable pump is a totally internal medical device connected to the arterial hepatic catheter during laparotomy.
The selection criteria were met in 47/319 studies. The complications of surgical and radiological medical devices connected to a port were found in 16 and 14 studies respectively. Meanwhile, complications with a fully implantable pump were reported in 17 studies. The total number of complications reported in studies evaluating patients with surgical or radiological catheter were 322 (322/948, 34%) and 261 (261/722, 36.1%) respectively. In studies evaluating patients with a fully implantable pump, the total number of complications was 237 (237/1502, 15.8%). In 18/319 studies the number of cycles was reported. The median number of cycles with surgically and radiologically implanted catheters was 8 and 6 respectively. The fully implantable pump allows a median number of 12 cycles.
The fully implantable pump, maintaining a continuous infusion through the system, allows the lowest risk for thrombosis and infection and the best median number of cycles of loco-regional chemotherapy in HAI.
肝动脉灌注(HAI)适用于治疗不可切除的结直肠癌肝转移,近期也被用作新辅助或辅助治疗。传统上采用基于氟嘧啶的化疗药物进行灌注,目前已对奥沙利铂或伊立替康进行了测试,并与全身化疗联合应用。
为评估医疗器械并发症的影响,我们检索了已发表的关于不可切除结直肠癌肝转移HAI的研究。根据所应用的医疗系统对并发症进行汇总:1)手术导管,2)放射学导管,3)完全植入式泵。手术导管从胃十二指肠动脉插入肝动脉。放射学导管通过经皮股动脉或经腋动脉途径插入肝动脉。完全植入式泵是一种完全内置的医疗器械,在剖腹手术期间与肝动脉导管相连。
47/319项研究符合入选标准。分别在16项和14项研究中发现了与端口相连的手术和放射学医疗器械的并发症。同时,17项研究报告了完全植入式泵的并发症。评估使用手术或放射学导管患者的研究中报告的并发症总数分别为322例(322/948,34%)和261例(261/722,36.1%)。在评估使用完全植入式泵患者的研究中,并发症总数为237例(237/1502,15.8%)。在18/319项研究中报告了周期数。手术植入导管和放射学植入导管的中位周期数分别为8和6。完全植入式泵的中位周期数为12。
完全植入式泵通过该系统维持持续输注,在HAI中发生血栓形成和感染的风险最低,局部区域化疗的中位周期数最佳。