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Completed

NCT Number: NCT05247164

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

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Cells, Circulating Neoplastic Processes Pancreatic Adenocarcinoma Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS San Raffaele Scientific Institute

Milan, 20132, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EUS-guided Portal Vein sampling

Procedure

Transgastric and Transhepatic Fine Needle Aspiration of a branch of the Portal Vein under EUS guidance.

A paired peripheral sample will be acquired.

Primary outcomes

  1. Proportion of patients with successful aspiration of portal blood

    Time frame: Day 1

    The proportion of patients with successful needle access to the portal circulation with subsequent successful aspiration of portal blood

  2. Proportion of patients with procedure-related Adverse Events

    Time frame: 30 days

    The proportion of patients experiencing procedure-related adverse events, such as bleeding or perihepatic collections.

Secondary outcomes

  1. Difference between Portal and Peripheral CTC concentration

    Time frame: Day 1

    CTC concentration [Count / 7.5 ml of blood]

  2. Portal CTC concentration according to clinical stage

    Time frame: Day 1

    CTC concentration [Count / 7.5 ml of blood]

  3. Baseline portal CTC concentration in patients with progressive versus non-progressive diseases

    Time frame: 24 months

    CTC concentration [Count / 7.5 ml of blood]

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Acronym: EUPhORIC

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Feb 18, 2022
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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