Pancreatic CancerEUPhORICNCT05247164
EUS-guided PORtal Vein Sampling for Circulating Tumor Cells in Pancreatic Cancer Patients
A study testing EUS-guided Portal Vein sampling in people with Pancreatic Cancer and Pancreatic Adenocarcinoma, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Adenocarcinoma
- What is being tested?
- EUS-guided Portal Vein sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteItaly
- Study dates
- 17 May 2022to 19 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pancreatic Cancer, Pancreatic Adenocarcinoma
- Being tested
- EUS-guided Portal Vein sampling
- Keywords
- Endoscopic Ultrasound, EUS, Portal blood, Circulating Tumor Cells, Fine Needle Aspiration
- Medical subject headings
- Pancreatic Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided Portal Vein samplingProcedure or surgery
Transgastric and Transhepatic Fine Needle Aspiration of a branch of the Portal Vein under EUS guidance.
A paired peripheral sample will be acquired.
| Study group | Role | What they receive |
|---|---|---|
| PDAC Patients | Experimental | Patients undergoing EUS for characterization of a PDAC lesion will receive EUS-guided portal blood sampling. Receives: Procedure: EUS-guided Portal Vein sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 30 days
Secondary outcomes (3)
Difference between Portal and Peripheral CTC concentration
CTC concentration [Count / 7.5 ml of blood]
Measured: Day 1
Portal CTC concentration according to clinical stage
CTC concentration [Count / 7.5 ml of blood]
Measured: Day 1
Baseline portal CTC concentration in patients with progressive versus non-progressive diseases
CTC concentration [Count / 7.5 ml of blood]
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start17 May 2022
- Primary completion22 Oct 2025
- Study completion19 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Vanella, IRCCS San Raffaele
- Investigators
- Giuseppe Vanella, Principal investigator, IRCCS San Raffaele Scientific Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247164
- Sponsor's protocol ID
- EUPhORIC
- Acronym
- EUPhORIC
- Status last verified
- Jan 2026
- First submitted
- 6 Feb 2022
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26341722Liu 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.
PubMed 29896289Pang 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.
PubMed 33309014Zhang 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.
PubMed 34675662
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS-guided PORtal Vein Sampling for Isolation, Enumeration and Profiling of Circulating Tumor Cells in Pancreatic Cancer Patients
- ClinicalTrials.gov ID
- NCT05247164
- Acronym / sponsor ID
- EUPhORIC / EUPhORIC
- Conditions
- Pancreatic Cancer, Pancreatic Adenocarcinoma
- Keywords
- Endoscopic Ultrasound, EUS, Portal blood, Circulating Tumor Cells, Fine Needle Aspiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 17 May 2022 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 19 Mar 2026 (actual)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PDAC Patients | Experimental | Procedure: EUS-guided Portal Vein samplingPatients undergoing EUS for characterization of a PDAC lesion will receive EUS-guided portal blood sampling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUS-guided Portal Vein samplingTransgastric and Transhepatic Fine Needle Aspiration of a branch of the Portal Vein under EUS guidance. A paired peripheral sample will be acquired. | Procedure or surgery | PDAC Patients |
Primary outcome
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
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.
3 secondary outcomes
Difference between Portal and Peripheral CTC concentration
Time frame: Day 1
Portal CTC concentration according to clinical stage
Time frame: Day 1
Baseline portal CTC concentration in patients with progressive versus non-progressive diseases
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Background: PubMed 26341722Catenacci 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.
- Background: PubMed 29896289Liu 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.
- Background: PubMed 33309014Pang 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.
- Background: PubMed 34675662Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Vanella principal investigator
IRCCS San Raffaele Scientific Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-guided Portal Vein sampling in people with Pancreatic Cancer and Pancreatic Adenocarcinoma, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with successful aspiration of portal blood (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05247164, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026; AzTrials last refreshed its copy on 2 Nov 2026.