• Felix J Hüttner, Tom Bruckner, Matthes Hackbusch, Jürgen Weitz, Ulrich Bork, Peter Kotschenreuther, Oliver Heupel, Sabine Kümmel, Hans J Schlitt, Matthias Mattulat, László Pintér, Christoph M Seiler, Carsten N Gutt, Hubertus S Nottberg, Alexander Pohl, Firas Ghanem, Thomas Meyer, Andreas Imdahl, Jens Neudecker, Verena A Müller, Tobias Gehrig, Mario Reineke, Moritz von Frankenberg, Guido Schumacher, Roland Hennes, André L Mihaljevic, Inga Rossion, Christina Klose, Meinhard Kieser, Markus W Büchler, Markus K Diener, and Phillip Knebel.
• Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.
• Ann. Surg. 2020 Dec 1; 272 (6): 950-960.

ObjectivesPORTAS-3 was designed to compare the frequency of pneumothorax or haemothorax in a primary open versus closed strategy for port implantation.Background DataThe implantation strategy for totally implantable venous access ports with the optimal benefit/risk ratio remains unclear.MethodsPORTAS-3 was a multicentre, randomized, controlled, parallel-group superiority trial. Adult patients with oncological disease scheduled for elective port implantation were randomized to a primary open or closed strategy. Primary endpoint was the rate of pneumothorax or haemothorax. Assuming a difference of 2.5% between the 2 groups, a sample size of 1154 patients was needed to prove superiority of the open group. A logistic regression model after the intention-to-treat principle was applied for analysis of the primary endpoint.ResultsBetween November 9, 2014 and September 5, 2016, 1205 patients were randomized. Of these, 1159 (open n = 583; closed n = 576) were finally analyzed. The rate of pneumothorax or haemothorax was significantly reduced with the open strategy [odds ratio 0.27, 95% confidence interval (CI) 0.09-0.88; P = 0.029]. Operation time was shorter for the closed strategy. Primary success rates, tolerability, morbidity, dose rate of radiation, and 30-day mortality did not differ significantly between the groups.ConclusionA primary open strategy by cut-down of the cephalic vein, if necessary enhanced by a modified Seldinger technique, reduces the frequency of pneumothorax or haemothorax after central venous port implantation significantly compared with a closed strategy by primary puncture of the subclavian vein without routine sonographic guidance. Therefore, open surgical cut-down should be the reference standard for port implantation in comparable cohorts.Trial RegistrationGerman Clinical Trials Register DRKS 00004900.

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