Contact information
Type
Scientific
Primary contact
Dr Roberto Biffi
ORCID ID
Contact details
via G. Ripamonti 435
Milan
20141
Italy
robert.biffi@ieo.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
IEO S16/199
Study information
Scientific title
Percutaneus subclavian versus internal jugular versus cephalic surgical venous cut-down for central venous access of totally implantable ports for long-term chemotherapy: a prospective randomised trial
Acronym
TIAP
Study hypothesis
The purpose of this prospective randomised trial is to compare a percutaneous approach to SVC (subclavian or internal jugular vein) with a surgical cut-down access to the cephalic vein, with respect to complication rates (early and late), global costs (including the costs for diagnosis and appropriate treatment of observed complications), and patients' compliance and satisfaction, to clarify whether or not there is any inherent superiority of one approach over another for this clinical indication.
Ethics approval
Ethics Committee of the European Institute of Oncology gave approval on the 25th February 1999 (ref: IEO S16/199)
Study design
Randomised interventional open single centre phase III three armed study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Solid tumours
Intervention
1. Percutaneous subclavian
2. Internal jugular
3. Cephalic surgical venous cut down
Ports and routes of access to central veins:
Patients were randomly assigned to undergo implantation of a single type of port, constructed of titanium and silicone rubber, with a attached 6-F polyurethane catheter tubing (Bard Port, Bard Inc., Salt Lake City, UT), through a percutaneous landmark access to internal jugular vein, a 2D-US-guided infraclavicular access to subclavian vein or a surgical cut-down access through the cephalic vein at deltoid–pectoralis groove. Generator of the assignment was separated from the executor; randomisation was intra-operatively carried out by the data manager of the trial using a computer-assisted procedure and communicated to the operators. Devices were implanted under local anaesthesia in an operating room or in an angiographic suite, using maximal sterile barrier precautions. A confirmatory chest X-ray was always obtained after the placement. Data from the implantation and follow-up of these patients were entered into a software registry and analysed by epidemiologists-biostatisticians.
A follow-up continued on an outpatient basis at regular intervals of 15 - 21 days until the device was removed, the patient died or the study was closed (30th June 2007). The planned minimum follow-up period was 6 months for each patient. Power and color Doppler ultrasonography of internal jugular and subclavian veins was carried out at regular intervals (1 and 4 months after implant) or anytime when clinically suggested by the appearance of arm or facial swelling and/or pain. Patients with positive or dubious ultrasound (US) scans underwent a neck-chest computerised tomography scan, with i.v. contrast medium administration. Implanted ports have been flushed with 20 ml of normal saline and then filled with sterile heparinised saline after each infusion of medication or blood withdrawal (5 ml of a solution containing 50 IU/ml). If the port remained unused for long periods of time, the heparin lock was changed once every 28 days. Complications were recorded according to the timing of occurrence: early (intra-operative and post-implantation period to first use) and late complications (occurring after the first chemotherapy course given through the device). Patients who died within 6 months were retained in the analysis and were recorded as having no late complications unless one was noted before death.
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measures
To evaluate early and late complications related to implant and use of the devices, related to different approaches and measured as:
1. Prevalence of peri-operative complications (pneumothorax, clinically relevant bleeding)
2. Prevalence of port-related bacteraemia, cutaneous site and pocket infections
3. Prevalence of malfunction of the device (obstruction of the line, dislocation of the catheter, etc.)
4. Prevalence of catheter break and embolisation
5. Prevalence of clinically evident and silent venous thrombosis
Secondary outcome measures
1. Costs for implant
2. Management of the devices and related complications
3. Evaluate the patients' compliance and satisfaction for the adopted procedure
4. Evaluate the quality of life of the patients
Overall trial start date
01/07/2003
Overall trial end date
31/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients (aged 18 - 75 years, either sex) bearing solid tumours who are candidate to chemotherapy treatment for at least 4 months
2. Informed signed consent
3. Performance status 0 - 2 (according to Eastern Cooperative Oncology Group [ECOG] score)
4. Platelets greater than 50,000/mm^3
5. Prothrombin time (quick) greater than 60%
6. White blood cells greater than 2500/mm^3
7. Life expectancy greater than 6 months
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
750 patients
Participant exclusion criteria
1. Severe hepatic failure (ascites, portal hypertension, jaundice or encephalopathy)
2. Renal failure (haemodyalisis and creatinine greater than 2.5 mg/dL)
3. Active infections
4. Coagulopathy
5. Inability to give an informed consent
Recruitment start date
01/07/2003
Recruitment end date
31/12/2006
Locations
Countries of recruitment
Italy
Trial participating centre
via G. Ripamonti 435
Milan
20141
Italy
Sponsor information
Organisation
European Institute of Oncology (Italy)
Sponsor details
via G. Ripamonti 435
Milan
20141
Italy
rosalba.lembo@ieo.it
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Italian Association for Cancer Research (Italy) (ref: 1126)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary