Pancreatic cancer Cancer Malignant neoplasm of pancreas
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient = 18 years 2. Confirmed or suspected pancreatic cancer referred for pancreaticoduodenectomy 3. Fit for general anaesthesia 4. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. Prisoners and adults lacking capacity to consent 2. Patients undergoing distal or total pancreatectomy 3. Contraindications to MR (implanted electronic devices, metallic foreign bodies, claustrophobia, body weight >140 kg or waist perimeter exceeding manufacturer‘s recommendations and others according to manufacturer’s recommendations and generally accepted guidelines)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients correctly identified by MRI as being ‘resectable’ (no lymph node, peritoneal or liver metastases) as determined by sensitivity and positive predictive values (PPV). Data collected at surgery (whether resection for pancreatic cancer goes ahead or not) and the preoperative MRI scan (whether metastases are identified or not). | — |
Secondary
| Measure | Time frame |
|---|---|
| Data collected at surgery and the preoperative MRI scan: 1. Proportion of patients correctly identified by MRI to have lymph node, peritoneal or liver metastases. Position of ‘pathological’ lymph nodes on MRI is correlated with the final histology 2. Intra- and inter-observer reliability of MRI 3. Optimal combination of MRI parameters to detect metastasis 4. Safety of MRI in this patient population 5. Feasibility parameters (recruitment) 6. Resource use and costs for a preliminary economic evaluation, collected during the patient’s hospital stay 7. Vital status of participants for 5 years after the last patient is recruited | — |
Countries
United Kingdom