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

NCT00600444 | Completed

• 1 other identifier: KSC01/08
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Primary success rate of the randomized intervention

  Assessed on the day of surgery (day 0)

Secondary Outcomes (1)

• Peri-/postoperative complication rate for the randomized intervention

  Assessed after 90 day post operation

Study Arms (2)

A

ACTIVE COMPARATOR

Venae Sectio technique will be used to insert totally implantable access port (TIAP) by a surgeon

Procedure: Venae sectio

B

EXPERIMENTAL

Punction of Vena Subclavia will be used to insert totally implantable access port (TIAP) by a radiologist.

Procedure: Punction of V. subclavia

Interventions

Venae sectio PROCEDURE

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

A

Punction of V. subclavia PROCEDURE

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

B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

University of Heidelberg

Heidelberg, Baden Würtemberg, 69120, Germany

Location

Related Publications (2)

• Knebel P, Lopez-Benitez R, Fischer L, Radeleff BA, Stampfl U, Bruckner T, Hennes R, Kieser M, Kauczor HU, Buchler MW, Seiler CM. Insertion of totally implantable venous access devices: an expertise-based, randomized, controlled trial (NCT00600444). Ann Surg. 2011 Jun;253(6):1111-7. doi: 10.1097/SLA.0b013e318214ba21.

  PMID: 21412146 DERIVED

• Knebel P, Fischer L, Cremonese E, Lopez-Benitez R, Stampfl U, Radeleff B, Kauczor HU, Buchler MW, Seiler CM. 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. Trials. 2008 Oct 24;9:60. doi: 10.1186/1745-6215-9-60.

  PMID: 18950491 DERIVED

MeSH Terms

Conditions

Neoplasms; Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Markus W Büchler, Prof. Dr.

  University of Heidelberg, Department of General, Visceral and Transplantation Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 14, 2008
• First Posted: January 25, 2008
• Study Start: February 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: January 27, 2010

Record last verified: 2008-05

Locations

DE (1)