BACKGROUND: Implanted central venous access is practiced extensively in oncology; however, information on the relevance of using the device with a valved catheter (Groshong), compared with an open-ended catheter, is scarce. The authors investigated the two types of catheters in a randomized trial using the same type of subcutaneous port and evaluated efficacy as well as early and late complications. METHODS:Three hundred four patients with malignant disease (solid tumors) who were eligible to receiveintravenous chemotherapy were accrued during a 15-month period. After providing informed consent, the patients were assigned randomly to implantation of a titanium and silicone, rubber port (Dome Port; Bard Inc., Salt Lake City, UT) attached either to an 8.0-F silastic Groshongtrade mark catheter tube (experimental group) or to a 9.6-F silastic open-ended catheter tube (control group). Both catheters were manufactured by Bard Inc. Implantation, care, and follow-up followed the same protocol guidelines until removal of the device, death, or ending of the study. Power and color Doppler ultrasound examinations of internal jugular and subclavian veins were performed at 1 month and at 4 months or at anytime when a venous 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 experimental 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 late complications in the experimental group (17.1%; 95% CI, 11.5-24.1%) compared 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 frequent late complication was the inability to draw blood samples (12.5% in the experimental group and 2% in the control group; P < 0.001). Sepsis was observed 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 groups, 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 justification for its superiority for more efficient use of the implantable device could not be substantiated. Copyright 2001 American Cancer Society.
RCT Entities:
BACKGROUND: Implanted central venous access is practiced extensively in oncology; however, information on the relevance of using the device with a valved catheter (Groshong), compared with an open-ended catheter, is scarce. The authors investigated the two types of catheters in a randomized trial using the same type of subcutaneous port and evaluated efficacy as well as early 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 assigned randomly to implantation of a titanium and silicone, rubber port (Dome Port; Bard Inc., Salt Lake City, UT) attached either to an 8.0-F silastic Groshongtrade mark catheter tube (experimental group) or to a 9.6-F silastic open-ended catheter tube (control group). Both catheters were manufactured by Bard Inc. Implantation, care, and follow-up followed the same protocol guidelines until removal of the device, death, or ending of the study. Power and color Doppler ultrasound examinations of internal jugular and subclavian veins were performed at 1 month and at 4 months or at anytime when a venous 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 experimental 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 late complications in the experimental group (17.1%; 95% CI, 11.5-24.1%) compared 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 frequent late complication was the inability to draw blood samples (12.5% in the experimental group and 2% in the control group; P < 0.001). Sepsis was observed 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 groups, 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 justification for its superiority for more efficient use of the implantable device could not be substantiated. Copyright 2001 American Cancer Society.
Authors: W Saber; T Moua; E C Williams; M Verso; G Agnelli; S Couban; A Young; M De Cicco; R Biffi; C J van Rooden; M V Huisman; D Fagnani; C Cimminiello; M Moia; M Magagnoli; S P Povoski; S F Malak; A Y Lee Journal: J Thromb Haemost Date: 2011-02 Impact factor: 5.824
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