Arru M, Aldrighetti L, Gremmo F, Ronzoni M, Angeli E, Caterini R, Ferla G
Department of Surgery, Scientific Institute San Raffaele Hospital, Milan - Italy.
J Vasc Access. 2000 Jul-Sep;1(3):93-9. doi: 10.1177/112972980000100305.
Introduction. Intra-Arterial Hepatic Chemotherapy (IAHC) based on floxuridine (FUdR) infusion is an effective treatment for hepatic metastases from colorectal cancer. A percutaneously implanted intra-arterial device may overcome the surgical stress of the laparotomic placement allowing an increase in the number of patients treated by IAHC. The aim of the present study is the comparative analysis of surgical and percutaneous transaxillary approaches to implant the catheter into the hepatic artery (HA) for IAHC. Materials and Methods. Between September 1993 and February 1999, 56 patients received an implantable infu-sion system [SynchroMed(R) (Medtronic, USA) or Port-a-cath(R) (Deltec, USA) connected to an external infusion pump (CADD(R) , Deltec, USA)] for IAHC. Twenty-eight patients (LPT group) underwent laparotomy to implant the catheter into the HA, the other 28 patients (PCT group) received a percutaneous catheter into the HA through a transaxillary percutaneous access. Indications for the laparotomic placement were: 1) synchronous metastases not suitable [technically unresectable or large (>40% of liver parenchyma) or multiple (> 3) metas-tases] for hepatic resection during colorectal surgery; 2) metachronous metastases treated by radical hepatic resection and subsequent adjuvant IAHC. Indications for percutaneous placement were: 1) metachronous metastases not suitable [see above] for hepatic resection; 2) metachronous metastases suitable for hepatic resection after neoadjuvant IAHC for tumor downstaging. All patients received IAHC based on continuous infusion of FU-dR (dose escalation 0.15-0.30 mg/kg/day for 14 days every 28 days) plus dexamethasone 28 mg. For the purpose of the study, the LPT group and the PCT group were comparatively analyzed in terms of age, gender, primary diagnosis, vascular anatomy of HA, ligation/embolization of aberrant HA, previous intestinal or hepatic surgery, contextual systemic chemotherapy, concomitant diseases. Safety and efficacy of surgical and percutaneous transaxillary approaches were then comparatively analyzed in terms of number of IAHC cycles adminis-tered, device-related complications causing temporary or definitive suppression of IAHC, biological costs of the procedures (procedure-related complications, postoperative pain and hospitalization). LPT cases without concomitant surgical procedure other than catheter placement (Cath-LPT group - 10 cases) were also compared with the PCT group for the same end points of the study. Results. LPT group and PCT group were comparable (p=n.s.) when evaluated for all the above listed variables. As for the end points of the study, mean postoperative hospitalization was 8.2+/-2.2 days in the LPT group and 1.8+/-0.7 days in the PCT group (p<0.0001), while mean analgesic requirements were 9.7+/-3.2 doses in the LPT group and 2+/-0.9 doses in the PCT group (p<0.0001). Mean number of IAHC cycles administered was 6.5+/-4.2 in the LPT group and 4.3+/-3.4 in the PCT group (p=0.038). Device-related complications causing temporary or de-finitive suppression of IAHC included catheter displacement in 10 cases (35.7%), HA thrombosis in 1 case (3.5%) and catheter occlusion in 1 case (3.5%) in the PCT group, while in the LPT group 1 case (3.5%) of catheter occlusion and 1 case (3.5%) of HA thrombosis occurred. The overall incidence of device-related complications causing temporary or definitive suppression of IAHC was 42.7% in the PCT group and 7.1% in the LPT group (p=0.005). Comparison of Cath-LPT group and the PCT group showed mean postoperative hospitalization of 5.5+/-0.7 days in the Cath-LPT group and 1.8+/-0.7 days in the PCT group (p<0.0001), and mean anal-gesic requirements of 8+/-3.1 doses in the Cath-LPT group and 2+/-0.9 in the PCT group (p<0.0001). Conclusions. Surgically implanted indwelling catheters for IAHC present lower incidence of device-related complications than percutaneous transaxillary implanted catheters. In spite of its irreversibility and significant biological costs, surgical implant is still advised when laparotomy has to be performed for other contextual procedures, such as colorectal or hepatic resection, while percutaneous transaxillary catheter placement is indicated for palliative or neoadjuvant IAHC.
引言。基于氟尿苷(FUdR)输注的肝动脉内化疗(IAHC)是治疗结直肠癌肝转移的有效方法。经皮植入的动脉内装置可克服剖腹放置带来的手术应激,从而增加接受IAHC治疗的患者数量。本研究的目的是对通过手术和经皮经腋窝途径将导管植入肝动脉(HA)以进行IAHC的方法进行比较分析。
材料与方法。1993年9月至1999年2月期间,56例患者接受了用于IAHC的可植入输注系统[SynchroMed®(美敦力公司,美国)或Port-a-cath®(德尔泰克公司,美国),连接至外部输注泵(CADD®,德尔泰克公司,美国)]。28例患者(LPT组)接受剖腹手术将导管植入HA,另外28例患者(PCT组)通过经腋窝经皮途径将导管植入HA。剖腹放置的指征为:1)结直肠癌手术期间同步转移不适合[技术上无法切除或较大(>肝实质的40%)或多发(>3个)转移灶]进行肝切除;2)异时转移经根治性肝切除及随后的辅助IAHC治疗。经皮放置的指征为:1)异时转移不适合[见上文]进行肝切除;2)异时转移在新辅助IAHC使肿瘤降期后适合进行肝切除。所有患者均接受基于持续输注FU-dR(剂量递增,每28天0.15 - 0.30 mg/kg/天,共14天)加地塞米松28 mg的IAHC。为了本研究的目的,对LPT组和PCT组在年龄、性别、原发诊断、HA的血管解剖、异常HA的结扎/栓塞、既往肠道或肝脏手术、同期全身化疗、伴随疾病方面进行了比较分析。然后从给予的IAHC周期数、导致IAHC暂时或永久停用的与装置相关的并发症、操作的生物学成本(与操作相关的并发症、术后疼痛和住院时间)方面对手术和经皮经腋窝途径的安全性和有效性进行了比较分析。还将仅进行导管放置(Cath-LPT组 - 10例)而无其他伴随手术的LPT病例与PCT组针对本研究的相同终点进行了比较。
结果。在对上述所有列出的变量进行评估时,LPT组和PCT组具有可比性(p =无显著差异)。至于研究的终点,LPT组术后平均住院时间为8.2±2.2天,PCT组为1.8±0.7天(p<0.0001),而LPT组平均镇痛需求为9.7±3.2剂,PCT组为2±0.9剂(p<0.0001)。LPT组给予的IAHC平均周期数为6.5±4.2,PCT组为4.3±3.4(p = 0.038)。PCT组中导致IAHC暂时或永久停用的与装置相关的并发症包括导管移位10例(35.7%)、HA血栓形成1例(3.5%)和导管阻塞1例(3.5%),而LPT组发生导管阻塞1例(3.5%)和HA血栓形成1例(3.5%)。导致IAHC暂时或永久停用的与装置相关的并发症的总发生率在PCT组为42.7%,在LPT组为7.1%(p = 0.005)。Cath-LPT组与PCT组的比较显示,Cath-LPT组术后平均住院时间为5.5±0.7天,PCT组为1.8±0.7天(p<0.0001),Cath-LPT组平均镇痛需求为8±3.1剂,PCT组为2±0.9剂(p<0.0001)。
结论。用于IAHC的手术植入留置导管与经皮经腋窝植入导管相比,与装置相关的并发症发生率更低。尽管手术植入具有不可逆性且生物学成本较高,但当因其他同期手术(如结直肠或肝切除)必须进行剖腹手术时,仍建议采用手术植入,而经皮经腋窝导管放置适用于姑息性或新辅助IAHC。