EUS-guided PORtal Vein Sampling for Circulating Tumor Cells in Pancreatic Cancer Patients

Study Overview
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Brief Summary
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The study aims at evaluating the feasibility and safety of EUS-guided Portal Circulation sampling for isolation, enumeration and profiling od Circulating Tumor Cells (CTC) in Pancreatic Cancer patients. Patients undergoing Endoscopic Ultrasound (EUS) for cyto/histological characterization of the neoplasia will receive an additional Fine Needle Aspiration sampling of a branch of the Portal Circulation to obtain a blood sample which will be processed for CTC enrichment, count and characterization.

Detailed Description
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Prognostic stratification of patients with Pancreatic Ductal Adenocarcinoma (PDAC) is still suboptimal, relying only on imaging studies and Carbohydrate Antigen 19.9 to drive important treatment decisions (e.g. surgery versus neoadjuvant chemotherapy). Circulating Tumor Cells (CTCs) have been poorly evaluated in this neoplasia as they are rarely detected in the peripheral blood, whereas they are more abundantly detected in the portal circulation below the hepatic filter. Most PDAC patients undergo Endoscopic Ultrasound (EUS) for cyto/histological characterization of the neoplasia. EUS-guided acquisition of portal blood for CTC evaluation has demonstrated its feasibility in preliminary studies without reducing the safety of the endoscopic procedure. The study aims at collecting portal blood from PDAC patients under EUS-guidance to evaluate whether concentration and characterization of CTCs has a prognostic significance and can aid in decision making. A paired peripheral blood sample will be acquired for comparison. Samples will be processed to obtain microfluidic enrichment of CTCs and stained with immunofluorescent antibodies for exclusion of hematopoietic cells and specific identification of CTCs, which will then be counted to obtain the blood concentration expressed as number of cells per 7.5 ml of blood. Patients will be followed every 60 days for a maximum of 24 months to assess the evolution of primary disease and clinical status.

Official Title
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EUS-guided PORtal Vein Sampling for Isolation, Enumeration and Profiling of Circulating Tumor Cells in Pancreatic Cancer Patients

Conditions
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Pancreatic Cancer, Pancreatic Adenocarcinoma

Intervention / Treatment
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* Procedure: EUS-guided Portal Vein sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient with a pancreatic solid lesion undergoing EUS with a rapid on-site confirmation of a pancreatic ductal adenocarcinoma patients primarily followed within San Raffaele Institute Exclusion Criteria: history of active non-pancreatic cancer coagulopathy (INR > 1.5; platelets < 70.000/ul) or use of non-withdrawable anticoagulant or antiplatelet known history or endosonographic signs of portal hypertension extensive invasion of portal vein precluding needle maneuvers pregnancy and breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PDAC Patients<br>Patients undergoing EUS for characterization of a PDAC lesion will receive EUS-guided portal blood sampling. | Procedure: EUS-guided Portal Vein sampling<br>* Transgastric and Transhepatic Fine Needle Aspiration of a branch of the Portal Vein under EUS guidance. A paired peripheral sample will be acquired.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with successful aspiration of portal blood | The proportion of patients with successful needle access to the portal circulation with subsequent successful aspiration of portal blood | Day 1 | 
| Proportion of patients with procedure-related Adverse Events | The proportion of patients experiencing procedure-related adverse events, such as bleeding or perihepatic collections. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between Portal and Peripheral CTC concentration | CTC concentration [Count / 7.5 ml of blood] | Day 1 | 
| Portal CTC concentration according to clinical stage | CTC concentration [Count / 7.5 ml of blood] | Day 1 | 
| Baseline portal CTC concentration in patients with progressive versus non-progressive diseases | CTC concentration [Count / 7.5 ml of blood] | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic Ultrasound, EUS, Portal blood, Circulating Tumor Cells, Fine Needle Aspiration