Totally Implantable Access Ports

INTERVENTION: 1. Percutaneous subclavian 2. Internal jugular 3. Cephalic surgical venous cut down Ports and routes of access to central veins: Patients were randomly assigned to undergo implantation of a single type of port, constructed of titanium and silicone rubber, with a attached 6‐F polyurethane catheter tubing (Bard Port, Bard Inc., Salt Lake City, UT), through a percutaneous landmark access to internal jugular vein, a 2D‐US‐guided infraclavicular access to subclavian vein or a surgical cut‐down access through the cephalic vein at deltoid?pectoralis groove. Generator of the assignment was separated from the executor; randomisation was intra‐operatively carried out by the data manager of the trial using a computer‐assisted procedure and communicated to the operators. Devices were implanted under local anaesthesia in an operating room or in an angiographic suite, using maximal sterile barrier precautions. A confirmatory chest X‐ray was always obtained after the placement. Data from the implantation and follow‐up of these patients were entered into a software registry and analysed by epidemiologists‐biostatisticians. A follow‐up continued on an outpatient basis at regular intervals of 15 ‐ 21 days until the device was removed, the patient died or the study was closed (30th June 2007). The planned minimum follow‐up period was 6 months for each patient. Power and color Doppler ultrasonography of internal jugular and subclavian veins was carried out at regular intervals (1 and 4 months after implant) or anytime when clinically suggested by the appearance of arm or facial swelling and/or pain. Patients with positive or dubious ultrasound (US) scans underwent a neck‐chest computerised tomography scan, with i.v. contrast medium administration. Implanted ports have been flushed with 20 ml of normal saline and then filled with sterile heparinised saline after each infusion of medication or blood withdrawal (5 ml of a solution containing 50 IU/ml). If the port remained unused for l CONDITION: Solid tumours ; Cancer ; Solid tumours PRIMARY OUTCOME: To evaluate early and late complications related to implant and use of the devices, related to different approaches and measured as: ; 1. Prevalence of peri‐operative complications (pneumothorax, clinically relevant bleeding); 2. Prevalence of port‐related bacteraemia, cutaneous site and pocket infections; 3. Prevalence of malfunction of the device (obstruction of the line, dislocation of the catheter, etc.); 4. Prevalence of catheter break and embolisation; 5. Prevalence of clinically evident and silent venous thrombosis SECONDARY OUTCOME: 1. Costs for implant; 2. Management of the devices and related complications; 3. Evaluate the patients' compliance and satisfaction for the adopted procedure; 4. Evaluate the quality of life of the patients INCLUSION CRITERIA: 1. Patients (aged 18 ‐ 75 years, either sex) bearing solid tumours who are candidate to chemotherapy treatment for at least 4 months 2. Informed signed consent 3. Performance status 0 ‐ 2 (according to Eastern Cooperative Oncology Group [ECOG] score) 4. Platelets greater than 50,000/mm^3 5. Prothrombin time (quick) greater than 60% 6. White blood cells greater than 2500/mm^3 7. Life expectancy greater than 6 months