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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Frequency of pneumothorax and haemothorax after primary open versus closed implantation strategies for insertion of a totally implantable venous access port in oncological patients: study protocol for a randomised controlled trial

Authors: Felix J Hüttner, Tom Bruckner, Ingo Alldinger, Roland Hennes, Alexis Ulrich, Markus W Büchler, Markus K Diener, Phillip Knebel

Published in: Trials | Issue 1/2015

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Abstract

Background

The insertion of central venous access devices, such as totally implantable venous access ports (TIVAPs), is routine in patients who need a safe and permanent venous access. The number of port implantations is increasing due to the development of innovative adjuvant and neo-adjuvant therapies. Currently, two different strategies are being routinely used: surgical cut-down of the cephalic vein (vena section) and direct puncture of the subclavian vein. The aim of this trial is to identify the strategy for the implantation of TIVAPs with the lowest risk of pneumothorax and haemothorax.

Methods/Design

The PORTAS-3 trial is designed as a multicentre, randomised controlled trial to compare two implantation strategies. A total of 1,154 patients will be randomised after giving written informed consent. Patients must be over 18 years of age and scheduled for primary implantation of a TIVAP on the designated side. The primary endpoint will be the frequency of pneumothorax and haemothorax after insertion of a TIVAP by one of two different strategies. The experimental intervention is as follows: open strategy, defined as surgical cut-down of the cephalic vein, supported by a rescue technique if necessary, and in the case of failure, direct puncture of the subclavian vein. The control intervention is as follows: direct puncture of the subclavian vein using the Seldinger technique guided by sonography, fluoroscopy or landmark technique. The trial duration is approximately 36 months, with a recruitment period of 18 months and a follow-up period of 30 days.

Discussion

The PORTAS-3 trial will compare two different TIVAP implantation strategies with regard to their individual risk of postoperative pneumothorax and haemothorax. Since TIVAP implantation is one of the most common procedures in general surgery, the results will be of interest for a large community of surgeons as well as oncologists and general practitioners. The pragmatic trial design ensures that the results will be generalizable to a wide range of patients.

Trial registration

The trial protocol was registered on 28 August 2014 with the German Clinical Trials Register (DRKS00004900). The World Health Organization’s Universal Trial Number is U1111-1142-4420.
Appendix
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Literature
1.
Niederhuber JE, Ensminger W, Gyves JW, Liepman M, Doan K, Cozzi E. Totally implanted venous and arterial access system to replace external catheters in cancer treatment. Surgery. 1982;92(4):706–12.PubMed
2.
Di Carlo I, Cordio S, La Greca G, Privitera G, Russello D, Puleo S, et al. Totally implantable venous access devices implanted surgically: a retrospective study on early and late complications. Arch Surg. 2001;136(9):1050–3.CrossRefPubMed
3.
European market for vascular access devices. 2012, iData Research Inc., Vancouver, British Columbia
4.
Biffi R, Orsi F, Pozzi S, Pace U, Bonomo G, Monfardini L, et al. Best choice of central venous insertion site for the prevention of catheter-related complications in adult patients who need cancer therapy: a randomized trial. Ann Oncol. 2009;20(5):935–40.CrossRefPubMed
5.
Gallichio MH, Kahn D, Lempert N, Conti DJ. Placement of a double lumen silastic catheter for hemodialysis access through the cephalic vein. J Am Coll Surg. 1994;178(2):171–2.PubMed
6.
Knebel P, Fischer L, Huesing J, Hennes R, Büchler MW, Seiler CM. Randomized clinical trial of a modified Seldinger technique for open central venous cannulation for implantable access devices. Br J Surg. 2009;96(2):159–65.CrossRefPubMed
7.
Lorch H, Zwaan M, Kagel C, Weiss HD. Central venous access ports placed by interventional radiologists: experience with 125 consecutive patients. Cardiovasc Intervent Radiol. 2001;24(3):180–4.CrossRefPubMed
8.
Lyon RD, Griggs KA, Johnson AM, Olsen JR. Long-term follow-up of upper extremity implanted venous access devices in oncology patients. J Vasc Interv Radiol. 1999;10(4):463–71.CrossRefPubMed
9.
Nocito A, Wildi S, Rufibach K, Clavien PA, Weber M. Randomized clinical trial comparing venous cutdown with the Seldinger technique for placement of implantable venous access ports. Br J Surg. 2009;96(10):1129–34.CrossRefPubMed
10.
Povoski SP. A prospective analysis of the cephalic vein cutdown approach for chronic indwelling central venous access in 100 consecutive cancer patients. Ann Surg Oncol. 2000;7(7):496–502.CrossRefPubMed
11.
Seiler CM, Frohlich BE, Dorsam UJ, Kienle P, Buchler MW, Knaebel HP. Surgical technique for totally implantable access ports (TIAP) needs improvement: a multivariate analysis of 400 patients. J Surg Oncol. 2006;93(1):24–9.CrossRefPubMed
12.
Shetty PC, Mody MK, Kastan DJ, Sharma RP, Burke MW, Venugopal C, et al. Outcome of 350 implanted chest ports placed by interventional radiologists. J Vasc Interv Radiol. 1997;8(6):991–5.CrossRefPubMed
13.
Simpson KR, Hovsepian DM, Picus D. Interventional radiologic placement of chest wall ports: results and complications in 161 consecutive placements. J Vasc Interv Radiol. 1997;8(2):189–95.CrossRefPubMed
14.
Biffi R, Pozzi S, Cenciarelli S, Zambelli M, Andreoni B. Treatment of pneumothorax as a complication of long-term central venous port placement in oncology patients. An observational study. J Vasc Access. 2001;2(3):129–36.PubMed
15.
Fischer L, Knebel P, Schröder S, Bruckner T, Diener MK, Hennes R, et al. Reasons for explantation of totally implantable access ports: a multivariate analysis of 385 consecutive patients. Ann Surg Oncol. 2008;15(4):1124–9.CrossRefPubMed
16.
Kluge A, Stroh H, Wagner D, Rauber K. The fluoroscopy-guided implantation of subcutaneous venous ports: the complications and long-term results. RöFo. 1998;169(1):63–7.PubMed
17.
Knebel P, Lopez-Benitez R, Fischer L, Radeleff BA, Stampfl U, Bruckner T, et al. Insertion of totally implantable venous access devices: an expertise-based, randomized, controlled trial (NCT00600444). Ann Surg. 2011;253(6):1111–7.CrossRefPubMed
18.
Biffi R, de Braud F, Orsi F, Pozzi S, Mauri S, Goldhirsch A, et al. Totally implantable central venous access ports for long-term chemotherapy. A prospective study analyzing complications and costs of 333 devices with a minimum follow-up of 180 days. Ann Oncol. 1998;9(7):767–73.CrossRefPubMed
19.
Doerr-Harim C, Bruckner T, Diener MK, Knebel P. Insights into surgical trials: methodological challenges and solutions. Langenbecks Arch Surg. 2014;399(3):273–8.CrossRefPubMed
20.
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240(2):205–13.CrossRefPubMedPubMedCentral
21.
22.
Dixon Jr JR. The International Conference on Harmonization Good Clinical Practice guideline. Qual Assur. 1998;6(2):65–74.PubMed
23.
Rickham PP. Human experimentation. Code of ethics of the world medical association. Declaration of Helsinki. Br Med J. 1964;2(5402):177.CrossRefPubMed
24.
Moher D, Schulz KF, Altman DG, and the CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. JAMA. 2001;285(15):1987–91.CrossRefPubMed
25.
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.CrossRefPubMed
26.
Lamperti M, Bodenham AR, Pittiruti M, Blaivas M, Augoustides JG, Elbarbary M, et al. International evidence-based recommendations on ultrasound-guided vascular access. Intensive Care Med. 2012;38(7):1105–17.CrossRefPubMed
27.
Brass P, Hellmich M, Kolodziej L, Schick G, Smith AF. Ultrasound guidance versus anatomical landmarks for subclavian or femoral vein catheterization. Cochrane Database Syst Rev. 2015;9;1:CD011447.
Metadata
Title
Frequency of pneumothorax and haemothorax after primary open versus closed implantation strategies for insertion of a totally implantable venous access port in oncological patients: study protocol for a randomised controlled trial
Authors
Felix J Hüttner
Tom Bruckner
Ingo Alldinger
Roland Hennes
Alexis Ulrich
Markus W Büchler
Markus K Diener
Phillip Knebel
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0643-z

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