A randomized, prospective trial of central venous ports connected to standard open-ended or groshong catheters in adult oncology patients

BACKGROUND. implanted central venous access is practiced extensively in onc ology; however, information on the relevance of using the device with a val ved catheter (Groshong), compared with an open-ended catheter, is scarce. T he authors investigated the two types of catheters in a randomized trial us ing the same type of subcutaneous port and evaluated efficacy as well as ea rly and late complications. METHODS. Three hundred four patients with malignant disease (solid tumors) who were eligible to receive intravenous chemotherapy were accrued during a 15-month period. After providing informed consent, the patients were assig ned randomly to implantation of a titanium and silicone, rubber port (Dome Port(TM); Bard Inc., Salt Lake City, UT) attached either to an 8.0-F silast ic Groshong(TM) catheter tube (experimental group) or to a 9.6-F silastic o pen-ended catheter tube (control group). Both catheters were manufactured b y Bard Inc. Implantation, care, and follow-up followed the same protocol gu idelines until removal of the device, death, or ending of the study. Power and color Doppler ultrasound examinations of internal jugular and subclavia n veins were performed at 1 month and at 4 months or at anytime when a veno us thrombosis was suspected. RESULTS. Three hundred two patients (99.3%) were evaluable, 150 patients in the control group and 152 in the experimental group. The median follow-up was 237 days. There was a trend toward more early complications in the expe rimental group (5.9%; 95% confidence interval [95% CI], 2.7-10.9%) than in the control group (2.7%; 95% CI, 0.7-6.7%), although the difference was not statistically significant (P = 0.26). There was also a trend toward more l ate complications in the experimental group (17.1%; 95% CI, 11.5-24.1%) com pared with the control group (10.7%; 95% CI, 6.2-16.7%; P = 0.13), although the difference, again, was not statistically significant, The most frequen t late complication was the inability to draw blood samples (12.5% in the e xperimental group and 2% in the control group; P < 0.001). Sepsis was obser ved in 1 patient and in 3 patients and venous thrombosis was observed in 6 patients and in 11 patients in the experimental and control treatment group s, respectively (P value not significant). CONCLUSIONS. In the tested clinical setting, the use of a Groshong catheter was not superior to a traditional, open-ended device in terms of early and late complications of the implant and its use. The theoretical justificati on for its superiority for more efficient use of the implantable device cou ld not be substantiated. (C) 2001 American Cancer Society.