Totally Implantable Access Ports

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN02260579

Enrollment

750

Registered

2009-03-31

Start date

2003-07-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid tumours Cancer Solid tumours

Interventions

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 ty

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 i

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026