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      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

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          Abstract

          Background

          Totally Implantable Access Ports (TIAP) are being extensively used world-wide and can be expected to gain further importance with the introduction of new neoadjuvant and adjuvant treatments in oncology. Two different techniques for the implantation can be selected: A direct puncture of a central vein and the utilization of a Seldinger device or the surgical Venae sectio. It is still unclear which technique has the optimal benefit/risk ratio for the patient.

          Design

          A single-center, expertise based randomized, controlled superiority trial to compare two different TIAP implantation techniques. 100 patients will be included and randomized pre-operatively. All patients aged 18 years or older scheduled for primary elective implantation of a TIAP under local anesthesia who signed the informed consent will be included. The primary endpoint is the primary success rate of the randomized technique. Control Intervention: Venae Sectio will be employed to insert a TIAP by a surgeon; Experimental intervention: Punction of V. Subclavia will be used to place a TIAP by a radiologist. Duration of study: Approximately 10 months, follow up time: 90 days.

          Organisation/Responsibility

          The PORTAS 2 – Trial will be conducted in accordance with the protocol and in compliance with the moral, ethical, and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989) and Good Clinical Practice (GCP). The Center of Clinical Trials at the Department of Surgery, University Hospital Heidelberg is responsible for design and conduct of the trial including randomization and documentation of patients' data. Data management and statistical analysis will be performed by the independent Institute for Medical Biometry and Informatics (IMBI), University of Heidelberg.

          Trial Registration

          The trial is registered at ClinicalTrials.gov (NCT00600444).

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          Most cited references17

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          Totally implantable venous access devices implanted surgically: a retrospective study on early and late complications.

          F Latteri, Paolo La Guardia, S Puleo … (2001)
          The techniques used for the implantation of totally implantable venous access devices (TIVADs) are the percutaneous approach and surgical cutdown; however, the choice is still controversial. The surgical cutdown approach may be beneficial to reduce the rate of complications. Retrospective review. A university hospital and a tertiary referral center. Patients undergoing a TIVAD implant at the First Surgical Clinic of the University of Catania in Catania, Italy, between January 1995 and December 1999, were considered for the study. All of the devices were implanted in an operating room under fluoroscopic control. The vein of choice was the cephalic vein. When the cephalic vein was not suitable for implantation, the external jugular vein or the axillary vein and its branches were used. The percutaneous approach to the subclavian vein or internal jugular vein was considered a last resort to implant a catheter. During the study period, 346 TIVADs were implanted in 344 patients. The procedure was performed with local anesthesia in 341 cases (98.5%), and only 2 patients (0.6%) required sedation for psychological reasons. Three patients (0.9%) had their TIVAD placed during a laparotomy. In 326 patients (94.2%), the devices were implanted in the cephalic vein. In the remaining cases, other veins were used with surgical cutdown. The mean time for the procedure was 15 minutes. Percutaneous access was never used, and no early mechanical complications were recorded. Only 6 patients (1.8%) in our study group had late complications (1 case of migration of the catheter, 2 cases of infection, and 3 cases of withdrawal occlusion). The catheter life ranged from 6 to 1487 days (mean time, 348 days). Our results confirm the safety, speed, and low cost of the open cutdown technique. This surgical procedure avoids both early and late complications that frequently occur with percutaneous access. Surgical cutdown should be considered the technique of choice to implant the TIVAD, especially in cancer patients.
          Article 0 comments Cited 31 times – based on 0 reviews     Review now
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            Central venous access ports placed by interventional radiologists: experience with 125 consecutive patients.

            H Lorch, M Zwaan, C Kagel … (2015)
            To assess safety and function of central venous port systems implanted percutaneously in the interventional radiology suite. One hundred and twenty-five consecutive ports in 123 patients were evaluated retrospectively. One hundred and twenty ports were implanted via the subclavian vein. Technical success was 100%. Fourteen patients (11.2%) experienced immediate procedural complications, all minor (pneumothorax 1.6%). During follow-up (4-343 days, mean service period 97.8 days), nine complications occurred, six of which were major. These were three port infections which led to hospitalization and port removal, one chamber penetration through the skin, and two port occlusions. Port removal as a result of complications was performed in six patients. Altogether, 20 complications occurred within a total of 11,056 days of service, which means 1.8 events per 1000 days of service. Percutaneous implantation of central venous port systems is safe and easy to perform. Complication rates of this study compare favorably with those of other radiological and surgical series.
            Article 0 comments Cited 22 times – based on 0 reviews     Review now
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              A prospective analysis of the cephalic vein cutdown approach for chronic indwelling central venous access in 100 consecutive cancer patients.

              Stephen Povoski (2000)
              Chronic indwelling central venous access devices (CICVAD) generally are placed by the percutaneous subclavian vein approach. The cephalic vein cutdown approach is used only infrequently. Although the technique has been well described, few prospective data are available on the cephalic vein cutdown approach. From September 9, 1998, to July 20, 1999, the cephalic vein cutdown approach was attempted in 100 consecutive cancer patients taken to the operating room with the intention of placing CICVAD. Median patient age was 54.5 years (range 18-88), with 46 men and 54 women. Twenty-five patients had gastrointestinal malignancies, 17 had breast cancer, 15 had lymphoma, 13 had lung cancer, 12 had leukemia, 5 had multiple myeloma, and 13 had other malignancies. Patients were followed prospectively for immediate and long-term outcome. CICVAD placement via the cephalic vein cutdown approach was successful in 82 patients; the remaining 18 patients required conversion to a percutaneous subclavian vein approach. The reasons for inability to place CICVAD via cephalic vein cutdown approach were a cephalic vein that was too small (10 patients), an absent cephalic vein (7 patients), and inability to traverse the angle of insertion of the cephalic vein into the subclavian vein (1 patient). There were 56 subcutaneous ports and 26 tunneled catheters. Median operating time was 44 minutes (range, 26-79 minutes). No postoperative pneumothorax occurred. Median catheter duration was 198 days (range, 0-513 days). Long-term complications included catheter-related bacteremia (6%), site infection (2%), deep venous thrombosis (5%), port pocket hematoma (1%), and superior vena cava stricture (1%). Thirty-seven percent of patients have died since CICVAD placement. Twenty-nine percent of the CICVADs have been removed. The cephalic vein cutdown approach was successful in 82% of patients. This approach is a safe and useful alternative to the percutaneous subclavian vein approach.
              Article 0 comments Cited 19 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): Trials
                Title: Trials
                Publisher: BioMed Central
                ISSN (Electronic): 1745-6215
                Publication date Collection: 2008
                Publication date (Electronic): 24 October 2008
                Volume: 9
                Page: 60
                Affiliations
                [1 ]Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Germany
                [2 ]Department of Diagnostic Radiology, University of Heidelberg, Germany
                Article
                Publisher ID: 1745-6215-9-60
                DOI: 10.1186/1745-6215-9-60
                PMC ID: 2579421
                PubMed ID: 18950491
                SO-VID: 1f6c2e87-7d4e-4cd3-8211-88fb131f75a9
                Copyright © Copyright © 2008 Knebel et al; licensee BioMed Central Ltd.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 30 June 2008
                Date accepted : 24 October 2008
                Categories
                Subject: Study Protocol

                ScienceOpen disciplines: Medicine
                Data availability:
                ScienceOpen disciplines: Medicine

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