Condition category
Cancer
Date applied
20/03/2009
Date assigned
31/03/2009
Last edited
31/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ieo.it/inglese/index.asp

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

Publication citations

Additional files

Editorial Notes