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Multicenter, randomized, controlled trial comparing complication rates of open and closed implantation strategies for insertion of a totally implantable venous access port (TIVAP) in oncological patients

Multicenter, randomized, controlled trial comparing complication rates of open and closed implantation strategies for insertion of a totally implantable venous access port (TIVAP) in oncological patients - PORTAS-3

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00004900
Enrollment
1154
Registered
2014-08-28
Start date
2014-11-10
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

OPS 5-399.5 - implantation and change of a permanent venous catheter (e.g. for chemotherapy or analgesia J93

Interventions

Group 1: open strategy: Cutdown of cephalican vein for TIVAP implantation. (using of guide wire and/or peel away sheath / vein dilatator is permitted). If the aforementioned fail, Implantation by punc

Sponsors

Klinik für Allgemein,- Viszeral,- und Transplantationschirurgie, Chirurgische Universitätsklinik Heidelberg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patient with oncological disease 2. scheduled for elective implantation of TIVAP 3. primary implantation on the designated side 4. Ability of subject to understand character and individual consequences of the clinical trial 5. Written informed consent

Exclusion criteria

Exclusion criteria: 1. participation in another clinical trial which could interfere with the primary endpoint of this study 2. impaired mental state or language problems

Design outcomes

Primary

MeasureTime frame
Frequency of pneumo-/hemothorax after TIVAP implantation diagnosed by means of a chest x-ray on the day of operation. Telephone interview on postoperative day 30

Secondary

MeasureTime frame
- Primary success rates - quality of life (EQ 5-D) - duration of intervention - mortality and morbidity until day 30. Assessment on day of operation and standardized telephone interview on day 30 post-OP

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 5, 2026