Trial document




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  DRKS00004900

Trial Description

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Title

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

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Trial Acronym

PORTAS-3

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URL of the Trial

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Brief Summary in Lay Language

Comparison of two different implantation techniques for totally implantable venous access ports (TIVAP) in an oncological setting. Oncological patients, who need a permanent venous access for chemotherapy or parenteral nutrition. The trial focuses on the rate of complications after the two different techniques. The aim is to find out wich implantation strategy has the best risk/benefit ratio for the patient.

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Brief Summary in Scientific Language

Pragmatic surgical randomized controlled trial comparing two different totally implantable venous access port implantation strategies in oncological patients, who require a long term central venous access for adjuvant medical treatment (chemotherapy / nutrition)

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00004900
  •   2014/08/28
  •   [---]*
  •   yes
  •   Approved
  •   S-308/2014 , Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   U1111-1142-4420 
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Health Condition or Problem studied

  •   OPS 5-399.5 - implantation and change of a permanent venous catheter (e.g. for chemotherapy or analgesia
  •   J93 -  Pneumothorax
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Interventions/Observational Groups

  •   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 puncture of the subclavian vein.
  •   closed strategy: Puncture of the subclavian vein with Seldinger technique for TIVAP implantation (guidance by fluoroscopy or ultrasound is permitted)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

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

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Secondary Outcome

- 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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/11/10
  •   1154
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Abteilung für Allgemein,- Viszeral,- und Transplantationschirurgie, Chirurgische Universitätsklinik Heidelberg
    • Mr.  Dr. med.  Phillip  Knebel 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Abteilung für Allgemein,- Viszeral,- und Transplantationschirurgie, Chirurgische Universitätsklinik Heidelberg
    • Mr.  Felix  Hüttner 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Studienzentrum der Deutschen Gesellschaft für Chirurgie Universitätsklinikum Heidelberg
    • Ms.  Inga  Wegener 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Aesculap AG
    • Am Aesculap Platz
    • 78532  Tuttlingen
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2016/10/07
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Trial Publications, Results and other Documents

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