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

April 10, 2026 updated by: Giuseppe Vanella, IRCCS San Raffaele

EUS-guided PORtal Vein Sampling for Isolation, Enumeration and Profiling of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20132
        • IRCCS San Raffaele Scientific Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PDAC Patients
Patients undergoing EUS for characterization of a PDAC lesion will receive EUS-guided portal blood sampling.
Procedure: EUS-guided Portal Vein sampling

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

A paired peripheral sample will be acquired.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1
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.
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Investigators

  • Principal Investigator: Giuseppe Vanella, IRCCS San Raffaele Scientific Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2022

Primary Completion (Actual)

October 22, 2025

Study Completion (Actual)

March 19, 2026

Study Registration Dates

First Submitted

February 6, 2022

First Submitted That Met QC Criteria

February 15, 2022

First Posted (Actual)

February 18, 2022

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUPhORIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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