Vascular Access in Cancer Patients - PICC vs PORT in a Randomized Controlled Trial.

NCT01971021 | Completed DMC

• 1 other identifier: EPN Linkoping 2013/56-31
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

As of today there is very limited scientific knowledge in whicj of the two vascular access devices (PICC-line or venous ports) that offers the lowest complicationrates in cancerpatients. The study group wants to clearify this unsolved matter by comparing the two systems. Our primary endpoint is the presens of catheter related venous thrombosis. We are also looking at all catheter related complications and patient satisfaction.

Conditions

Focus of Study

Outcome Measures

Primary Outcomes (1)

• The occurence of catheter related venous thrombosis

  regular follow-ups at month 1, 3, 6 and 12.

  Upon clinical suspiscion during the one the patient i enrolled in the study

Study Arms (2)

PICC-line

ACTIVE COMPARATOR

PICC line insertion.

Device: PICC or subcutaneous venous port

PORT

ACTIVE COMPARATOR

Subcutaneous venous port insertion

Device: PICC or subcutaneous venous port

Interventions

PICC or subcutaneous venous port DEVICE

PICC-line; PORT

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cancer treatment with need for central venous access
• Age \>18 yrs
• Suspected survival \> 4 weeks
• Need of central venous access \>4 weeks

You may not qualify if:

• Ongoing uncontrolled systemic infection
• Prescence of significant thrombosis/stenosis in arm or central veins
• Unability to communicate
• Probable upcoming need for dialysis fistula

Sponsors & Collaborators

• Linkoeping University: lead
• Ryhov County Hospital: collaborator

Study Sites (1)

Dept of Oncology

Jönköping, 551 11, Sweden

Location

Related Publications (3)

• Utas A, Seifert S, Taxbro K. Peripherally inserted central catheters versus implanted port catheters in patients with breast cancer: a post hoc analysis of the PICCPORT randomised controlled trial. BJA Open. 2025 Feb 4;13:100377. doi: 10.1016/j.bjao.2025.100377. eCollection 2025 Mar.

  PMID: 39991709 DERIVED

• Taxbro K, Hammarskjold F, Juhlin D, Hagman H, Bernfort L, Berg S. Cost analysis comparison between peripherally inserted central catheters and implanted chest ports in patients with cancer-A health economic evaluation of the PICCPORT trial. Acta Anaesthesiol Scand. 2020 Mar;64(3):385-393. doi: 10.1111/aas.13505. Epub 2019 Nov 27.

  PMID: 31721153 DERIVED

• Taxbro K, Hammarskjold F, Thelin B, Lewin F, Hagman H, Hanberger H, Berg S. Clinical impact of peripherally inserted central catheters vs implanted port catheters in patients with cancer: an open-label, randomised, two-centre trial. Br J Anaesth. 2019 Jun;122(6):734-741. doi: 10.1016/j.bja.2019.01.038. Epub 2019 Apr 17.

  PMID: 31005243 DERIVED

MeSH Terms

Interventions

Catheterization, Peripheral

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Consultant in Anesthesia and Intensive Care

Model Details: open label pragmatic

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: October 28, 2013
• Study Start: April 1, 2013
• Primary Completion: January 29, 2018
• Last Updated: January 30, 2018

Record last verified: 2018-01

Locations

SE (1)