PORTAS 2, Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port

Conditions

Cancer

Keywords

permanent venous access, chemotherapy, parenteral nutrition, Patients with a benign and/or malignant diseases which demand a safe and permanent venous access, e.g. for chemotherapy and/or parenteral nutrition, benign diseases, malignant diseases

Brief summary

The purpose of this trial is to investigate if the success rate of punction the vena subclavia (99% in retrospective studies) will be 15% higher than the success rate of venae sectio (80% in retro and prospective studies) for implantation of a totally implantable access ports.

Nickel F, Probst P, Studier-Fischer A, Nienhüser H, Pauly J, Kowalewski KF, Weiterer S, Knebel P, Diener MK, Weigand MA, Büchler MW, Schmidt T, Müller-Stich BP.

2021-01-1112 citations

10.1186/s13063-020-04966-z

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

Felix J. Hüttner, Tom Bruckner, Ingo Alldinger, Roland Hennes, Alexis Ulrich et al. (8 authors)

Trials2015-03-3013 citations

10.1186/s13063-015-0643-z

Protocol of an expertise based randomized trial comparing surgical Venae Sectio versus radiological puncture of Vena Subclavia for insertion of Totally Implantable Access Port in oncological patients.

Knebel P, Fischer L, Cremonese E, Lopez-Benitez R, Stampfl U, Radeleff B, Kauczor HU, Büchler MW, Seiler CM.

2008-10-244 citations

10.1186/1745-6215-9-60

Interventions

PROCEDUREVenae sectio

surgical preparation of the cephalic vene to insert a totally implantable access port.

PROCEDUREPunction of V. subclavia

radiological punction of the v. subclavia with Seldinger technique to implant a totally implantable access port

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

Inclusion criteria

* Age equal or greater than 18 years * Patients scheduled for primary elective implantation of TIAP

Exclusion criteria

* Participation in another clinical trial which could interfere with the primary endpoint of this study * Lack of compliance * Impaired mental state or language problem * Patients with known allergy to contrast agent

Design outcomes

Primary

Measure	Time frame
Primary success rate of the randomized intervention	Assessed on the day of surgery (day 0)

Secondary

Measure	Time frame
Peri-/postoperative complication rate for the randomized intervention	Assessed after 90 day post operation

Countries

Germany

Outcome results

None listed