None listed
Conditions
Brief summary
This study will look at the safety and feasibility of endoscopic ultrasound (EUS) guided portal vein blood sampling as an ultimate staging procedure in patients with pancreatic cancer. Who is it for? You may be eligible to join this study if you have been diagnosed with metastatic pancreatic cancer, locally advanced pancreatic cancer, or resectable pancreatic cancer. Study details All study participants will undergo endoscopic ultrasound (EUS) guided portal vein blood sampling. EUS is a procedure that safely allows the imaging of the digestive tract and surrounding tissue through ultrasound testing. The use of EUS is currently the preferred method for sampling pancreatic masses. The portal vein is a blood vessel that provides blood to the pancreas, and other gastrointestinal organs. Blood samples taken from the portal vein can be used to determine if pancreatic cancer cells are present, providing a useful technique for diagnosing pancreatic cancer. This procedure will involve finding portal vein under EUS guidance, and EUS portal vein sampling is done via a trans-hepatic approach that allows the liver tissue to act as a cushion that seals the needle tract, reducing the risk of bleeding complications. Blood samples will be analysed to count circulating tumour cells, which can be used for molecular characterisation of pancreatic cancers. A way to detect these is to analyse the % of mutated KRAS; a specific protein found in over 90% of patients with pancreatic cancer. Unfortunately, techniques cannot reliably detect small numbers of mutant KRAS copies. In peripheral blood samples, there is only a reported sensitivity of approximately 50% in patients with pancreatic cancer. This may be higher in portal venous samples where there is no filtering by the liver. All participants will also be monitored for safety for up to 7 days post procedure. Final follow-up will occur at 6 months. It is hoped that EUS guided portal vein blood sampling could represent the most sensitive technique for biological staging in pancreatic cancer.
Interventions
EUS guided portal vein sampling as an ultimate staging procedure in patients with pancreatic cancer: a feasibility study.
The initial stages of the study will only involve patients with metastatic pancreatic cancer and thus very limited life expectancy. Once deemed safe, the study can then include patients with locally advanced or resectable disease. All aspects of this study will be discussed with each patient during the recruitment process. An information sheet will be provided, and each pat
EUS guided portal vein sampling as an ultimate staging procedure in patients with pancreatic cancer: a feasibility study. The initial stages of the study will only involve patients with metastatic pancreatic cancer and thus very limited life expectancy. Once deemed safe, the study can then include patients with locally advanced or resectable disease. All aspects of this study will be discussed with each patient during the recruitment process. An information sheet will be provided, and each patient will be given the opportunity to discuss this study will a medical practitioner, friends or family prior to involvement. Each participant will give written, informed consent and will be free to withdrawal from the study at any time. Management of anti-coagulants and anti-platelets will be organised prior to the procedure as per the standard RAH Gastroenterology policies. A 5 ml sample of peripheral blood will be taken on the day of (prior to) the procedure. Patients will also be given prophylactic intravenous antibiotics 30 minutes prior to the procedure: 1. 1 gm Amoxycillin, 500mg Metronidazole and 6mg/kg dose of Gentamicin 2. For those with GFR <60 mL/minute: 1gm Ceftriaxone and 500mg Metronidazole The endoscopist will administer the intervention. Following standard EUS FNA of the mass lesion with a linear-array echoendoscope, the intra-hepatic branches of the portal vein will be located. To decrease the risk of bleeding, the site of portal vein puncture will be in an area where the needle will travel at least 15mm through liver parenchyma (i.e. there will be at least 15mm of hepatic tissue between the scope and the portal vein puncture site). Puncture of the portal vein will be done using a 22-gauge EUS FNA needle. The stylet within the needle will then be withdrawn and aspiration of blood will confirm the position of the needle. A 5 ml sample of portal venous blood will be aspirated. The samples are stored at room temperature (15-30 degrees Celsius) for testing that will be done within 96 hours. For KRAS mutation analyses, 5 ml of peripheral blood and 5ml of portal venous blood will be collected in tubes designed to stablise the RNA (KRAS seven mutations detection kit). The tubes will be processed (extraction and purification) according to the manufacturers’ instructions . Patients will be monitored for 90 minutes in our recovery unit for complications and pain scores. Blood tests will be done within 24 hours to monitor for any significant decline in haemoglobin.
Sponsors
The Royal Adelaide Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
30 patients who are referred to our unit for EUS guided FNA for either suspected (i) metastatic pancreatic cancer; (ii) locally advanced pancreatic cancer or (iii) resectable pancreatic cancer will be recruited for EUS guided portal vein sampling. i- metastatic pancreatic cancer: imaging evidence of a pancreatic mass with overt discrete lesion(s) in the liver or distant organs. ii- locally advanced pancreatic cancer: imaging evidence of a pancreatic mass that involved the adjacent organs or vasculatures (SMV, SMA, PV or hepatic artery), without overt evidence of hepatic or distant metastasis. iii- resectable pancreatic cancer: imaging evidence of an isolate mass in the pancreas without involvement of adjacent organs, vasculatures or distant metastasis.
Exclusion criteria
1. Coagulopathy or thrombocytopenia. 2. Complete portal vein thrombosis, especially those extending into the hilum and liver. 3. Portal Hypertension (detected via EUS )
Outcome results
None listed