Endoscopic Ultrasound Guided portal vein sampling as an ultimate staging procedure in patients with pancreatic cancer: a feasibility study.

Recruiting

• Conditions: Pancreatic Cancer; Cancer - Pancreatic

• Registration Number: ACTRN12617001242314
• Lead Sponsor: The Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-25
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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 )

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate the differences in the % of KRAS mutations found in circulating cell free tumour DNA between the groups of patients treated for: <br>1. metastatic pancreatic cancer;<br>2. Locally advanced pancreatic cancer;<br>3. Resectable pancreatic cancer.<br><br>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.[The samples are stored at room temperature (15-30 degrees Celsius) for testing that will be done within 96 hours.]