Felix J Hüttner1,2, Tom Bruckner3, Matthes Hackbusch3, Jürgen Weitz4, Ulrich Bork4, Peter Kotschenreuther5, Oliver Heupel5, Sabine Kümmel6, Hans J Schlitt6, Matthias Mattulat7, László Pintér8, Christoph M Seiler9, Carsten N Gutt10, Hubertus S Nottberg11, Alexander Pohl12, Firas Ghanem13, Thomas Meyer14, Andreas Imdahl15, Jens Neudecker16, Verena A Müller16, Tobias Gehrig17, Mario Reineke18, Moritz von Frankenberg19, Guido Schumacher20, Roland Hennes1,21, André L Mihaljevic1, Inga Rossion2, Christina Klose3, Meinhard Kieser3, Markus W Büchler1, Markus K Diener1,2, Phillip Knebel1,2. 1. Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany. 2. Study Center of the German Surgical Society (SDGC), University of Heidelberg, Heidelberg, Germany. 3. Institute of Medical Biometry and Informatics (IMBI), University of Heidelberg, Heidelberg, Germany. 4. Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Dresden Technical University, National Center for Tumor Diseases Dresden, Dresden, Germany. 5. Department of General, Visceral, Thoracic and Vascular Surgery, Klinikum Passau, Passau, Germany. 6. Department of Surgery, Regensburg University Hospital, Regensburg, Germany. 7. Department of General Surgery, Alb Fils Hospitals, Göppingen, Germany. 8. Department of General, Visceral, Thoracic and Vascular Surgery, Lukas Hospital Neuss, Neuss, Germany. 9. Department of General, Visceral and Vascular Surgery, Joseph Hospital Warendorf, Warendorf, Germany. 10. Department of General, Visceral, Thoracic and Vascular Surgery, Memmingen Hospital, Memmingen, Germany. 11. Department of General, Visceral and Vascular Surgery, Evangelical Hospitals, Gelsenkirchen, Germany. 12. Department of Surgery, Park Hospital Weissensee, Berlin, Germany. 13. Department of Visceral and Thoracic Surgery, Ingolstadt Hospital, Ingolstadt, Germany. 14. Colorectal Cancer Center, Anregiomed Hospital Ansbach, Ansbach, Germany. 15. Department of Visceral, Thoracic and Vascular Surgery, Heidenheim Rural District Hospitals gGmbH, Heidenheim, Germany. 16. Department of Surgery, Charité - University Medicine Berlin, Central Charité Campus and Virchow Hospital Campus, Berlin, Germany. 17. Department of General and Visceral Surgery, Sinsheim Hospital, Sinsheim, Germany. 18. Department of General and Visceral Surgery, Medius Hospital Nürtingen, Nürtingen, Germany. 19. Department of Surgery, Salem Medical Center, Heidelberg, Germany. 20. Department of Surgery, Braunschweig Municipal Hospital gGmbH, Braunschweig, Germany. 21. Heidelberg Port Center, University of Heidelberg, Heidelberg, Germany.
Abstract
OBJECTIVES: PORTAS-3 was designed to compare the frequency of pneumothorax or haemothorax in a primary open versus closed strategy for port implantation. BACKGROUND DATA: The implantation strategy for totally implantable venous access ports with the optimal benefit/risk ratio remains unclear. METHODS: PORTAS-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. RESULTS: Between 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. CONCLUSION: A 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 REGISTRATION: German Clinical Trials Register DRKS 00004900.
OBJECTIVES: PORTAS-3 was designed to compare the frequency of pneumothorax or haemothorax in a primary open versus closed strategy for port implantation. BACKGROUND DATA: The implantation strategy for totally implantable venous access ports with the optimal benefit/risk ratio remains unclear. METHODS: PORTAS-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. RESULTS: Between 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. CONCLUSION: A 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 REGISTRATION: German Clinical Trials Register DRKS 00004900.
Authors: Thomas Vogel; Dina Schippers; Balqees Aldarweesh; Ilaria Pergolini; Martina Stollreiter; Klaus Wagner; Dirk Wilhelm; Helmut Friess; Michael Kranzfelder Journal: Int J Comput Assist Radiol Surg Date: 2021-05-17 Impact factor: 2.924
Authors: Felix Becker; Lennart A Wurche; Martina Darscht; Andreas Pascher; Benjamin Struecker Journal: Langenbecks Arch Surg Date: 2021-02-07 Impact factor: 3.445