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

NCT05247164 | Completed

• 1 other identifier: EUPhORIC
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer; Pancreatic Adenocarcinoma

Keywords

Endoscopic Ultrasound; EUS; Portal blood; Circulating Tumor Cells; Fine Needle Aspiration

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Difference between Portal and Peripheral CTC concentration

  Day 1

• Portal CTC concentration according to clinical stage

  Day 1

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

  24 months

Study Arms (1)

PDAC Patients

EXPERIMENTAL

Patients undergoing EUS for characterization of a PDAC lesion will receive EUS-guided portal blood sampling.

Procedure: EUS-guided Portal Vein sampling

Interventions

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.

PDAC Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele Scientific Institute

Milan, 20132, Italy

Location

Related Publications (4)

• Catenacci DV, Chapman CG, Xu P, Koons A, Konda VJ, Siddiqui UD, Waxman I. Acquisition of Portal Venous Circulating Tumor Cells From Patients With Pancreaticobiliary Cancers by Endoscopic Ultrasound. Gastroenterology. 2015 Dec;149(7):1794-1803.e4. doi: 10.1053/j.gastro.2015.08.050. Epub 2015 Sep 2.

  PMID: 26341722 BACKGROUND

• Liu X, Li C, Li J, Yu T, Zhou G, Cheng J, Li G, Zhou Y, Lou W, Wang X, Gong G, Liu L, Chen Y. Detection of CTCs in portal vein was associated with intrahepatic metastases and prognosis in patients with advanced pancreatic cancer. J Cancer. 2018 May 22;9(11):2038-2045. doi: 10.7150/jca.23989. eCollection 2018.

  PMID: 29896289 BACKGROUND

• Pang TCY, Po JW, Becker TM, Goldstein D, Pirola RC, Wilson JS, Apte MV. Circulating tumour cells in pancreatic cancer: A systematic review and meta-analysis of clinicopathological implications. Pancreatology. 2021 Jan;21(1):103-114. doi: 10.1016/j.pan.2020.11.022. Epub 2020 Dec 3.

  PMID: 33309014 BACKGROUND

• Zhang Y, Su H, Wang H, Xu C, Zhou S, Zhao J, Shen S, Xu G, Wang L, Zou X, Zhang S, Lv Y. Endoscopic Ultrasound-Guided Acquisition of Portal Venous Circulating Tumor Cells as a Potential Diagnostic and Prognostic Tool for Pancreatic Cancer. Cancer Manag Res. 2021 Oct 5;13:7649-7661. doi: 10.2147/CMAR.S330473. eCollection 2021.

  PMID: 34675662 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

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

Study Officials

• Giuseppe Vanella

  IRCCS San Raffaele Scientific Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2022
• First Posted: February 18, 2022
• Study Start: May 17, 2022
• Primary Completion: October 22, 2025
• Study Completion: March 19, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)