Randomized clinical trial of a modified Seldinger technique for open central venous cannulation for implantable access devices.

摘要

INTRODUCTION: Totally implantable access ports (TIAPs) are often used for patients who need permanent venous access. The primary success rate using direct open insertion is about 80 per cent, so rescue strategies are needed. This study compared the primary success rates of standard open insertion and a modified Seldinger technique. METHODS: This randomized trial recruited 164 patients scheduled for primary implantation of a TIAP and compared two interventions. The primary endpoint was the success rate of the implantation technique. RESULTS: The primary success rates were similar: 66 (80 per cent) of 82 patients who had standard open insertion versus 69 (84 per cent) of 82 patients undergoing the modified Seldinger method (P = 0.686). A logistic mixed regression analysis including treatment group, age, Karnofsky index, body mass index and surgeon's experience showed no advantage for the Seldinger method: odds ratio 1.30 (95 per cent confidence interval 0.62 to 2.70). TIAPs were eventually implanted successfully in 163 (99.4 per cent) of 164 patients. In 11 patients randomized to standard surgery, the Seldinger method was a successful rescue strategy. CONCLUSION: The primary success rate was similar for both open insertion methods. The modified Seldinger method is useful if standard open insertion fails. Registration number: ISRCTN 52368201 (http://www.controlled-trials.com).