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Primary Open Versus Closed Implantation Strategy for Totally Implantable Venous Access Ports: The Multicentre Randomized Controlled PORTAS-3 Trial (DRKS 00004900).

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.

journal_name

Ann Surg

journal_title

Annals of surgery

authors

Hüttner FJ,Bruckner T,Hackbusch M,Weitz J,Bork U,Kotschenreuther P,Heupel O,Kümmel S,Schlitt HJ,Mattulat M,Pintér L,Seiler CM,Gutt CN,Nottberg HS,Pohl A,Ghanem F,Meyer T,Imdahl A,Neudecker J,Müller VA,Gehrig T,R

doi

10.1097/SLA.0000000000003705

subject

Has Abstract

pub_date

2020-12-01 00:00:00

pages

950-960

issue

eissn

0003-4932

issn

1528-1140

pii

00000658-202012000-00018

journal_volume

272

pub_type

杂志文章

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Primary Open Versus Closed Implantation Strategy for Totally Implantable Venous Access Ports: The Multicentre Randomized Controlled PORTAS-3 Trial (DRKS 00004900).