None listed
Conditions
Brief summary
This study is evaluating a new technology called intracardiac echocardiography (ICE) to assess if tumours are compressing, or invading the major abdominal blood vessel, the inferior vena cava (IVC). Who is it for? You may be eligible for this study if you are an adult with a retroperitoneal sarcoma who has radiological evidence (CT/MRI) demonstrating compression or involvement of the IVC, and are scheduled for tumour resection at Sir Charles Gairdner Hospital in Perth, Western Australia. Study details Participants will undergo ICE which is a day case procedure performed under local anaesthetic, involving passing a small catheter into the IVC to assess the degree of involvement of the tumour. It is hoped that by accurately distinguishing between patients with true IVC invasion and those with compression preoperatively will allow us to reduce unnecessary additional invasive procedures in patients that they do not ultimately need. This approach will allow for more effective scheduling of the operative lists and improve efficient use of theatre resources, including staff.
Interventions
Pre-operative intravenous ultrasound (IVUS) scanning using intracardiac echography (ICE) of the inferior vena cava (IVC) to assess tumour invasion from tumour compression in patients with large right sided retroperitoneal sarcomas with Computed Tomography and or Magnetic Resonance Imaging suggestive of IVC involvement.
The IVUS procedure is a day case procedure and will be performed under local anaesthesia with or without light sedation by a Specialist Interventional Radiologist. The procedure
Pre-operative intravenous ultrasound (IVUS) scanning using intracardiac echography (ICE) of the inferior vena cava (IVC) to assess tumour invasion from tumour compression in patients with large right sided retroperitoneal sarcomas with Computed Tomography and or Magnetic Resonance Imaging suggestive of IVC involvement. The IVUS procedure is a day case procedure and will be performed under local anaesthesia with or without light sedation by a Specialist Interventional Radiologist. The procedure involves passing a 8-10F ICE catheter into the IVC either via the femoral veins or internal jugular veins. The ICE catheter will be advances to the area of interest to assess if the tumour is involving the IVC or only compressing due to mass effect. The duration of the ICE procedure is approximately 30-45 minutes. A draft report will be created but not published until after the surgery. The primary surgeons, who will be assessing involvement/compression at the time of surgery will be blinded to the results of the ICE procedure.
Sponsors
Sir Charles Gairdner Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with right sided retroperitoneal soft tissue sarcoma with computerised tomography (CT) or magnetic resonance imaging (MRI) demonstrating compression or involvement of the IVC
Exclusion criteria
Patient without any imaging suggestive of IVC compression or tumour infiltration Patients not suitable for open surgical resection of tumour Patients without adequate venous access for ICE imaging Patients with known presence of deep vein thrombosis Patients with poor spoken and/or written English language comprehension Pregnancy
Outcome results
None listed