Solid Pancreatic NeoplasmsLE-VASCNCT03738280
Non-hypovascular Solid Pancreatic Lesions: Role of EUS
An observational study of Solid Pancreatic Neoplasms and Endoscopic Ultrasound, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial summary
Vascular pattern of solid pancreatic lesions (SPLs) has been investigated by different abdominal imaging modalities and by contrast-enhanced endoscopic ultrasonography (CE-EUS). Compared with surrounding pancreatic parenchyma three different patterns have been described: hypo-, iso-, and hypervascular. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Pancreatic Neoplasms, Endoscopic Ultrasound
- What is being tested?
- Endoscopic ultrasound-fine needle biopsy
- How many people
- 154 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2016to May 2019
- Phase
- Observational
- 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
Study population: All consecutive patients fulfilling inclusion and exclusion criteria will be included in the study.
Who may be able to join
- Presence of one or more solid pancreatic lesions preliminary evaluated by contrast-enhanced computed tomography (CE-CT) and/or contrast enhanced magnetic resonance imaging (CE-MRI) reporting a non-hypovascular contrast pattern (e.g., iso- or hypervascular).
Who cannot join
- Patients with associated chronic pancreatitis features (e.g., pancreatic calcifications)
- Lesion with hypovascular pattern at CE-EUS.
- Lesion not found or non pancreatic at EUS.
- Patients refusing to be included in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of EUS in Differential Diagnosis and Malignancy Prediction of Non-hypovascular Solid Pancreatic Lesions: A Prospective Observational Study
Vascular pattern of solid pancreatic lesions (SPLs) has been investigated by different abdominal imaging modalities and by contrast-enhanced endoscopic ultrasonography (CE-EUS). Compared with surrounding pancreatic parenchyma three different patterns have been described: hypo-, iso-, and hypervascular. The majority of SPLs are hypovascular, and the diagnostic relevance of hypoenhanced pattern to predict pancreatic adenocarcinoma (PDAC) is well established. Differently, iso- and hypervascular pattern is not specific and can be expressed by several SPLs, with different clinical behavior and management. To date, poor is know about the role of EUS in differential diagnosis of non-hypovascular SPLs and features associated with malignancy.
- Conditions
- Solid Pancreatic Neoplasms, Endoscopic Ultrasound
- Being tested
- Endoscopic ultrasound-fine needle biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasound-fine needle biopsyDiagnostic test
Patients with non-hypovascular solid pancreatic lesion undergo endoscopic ultrasound-fine needle biopsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Upstream dilation of the main pancreatic duct
Percentage of cases with upstream dilation of main pancreatic duct will be recorded.
Measured: 6 months
Vascular pattern (iso or hypervascular)
Percentage of cases with iso-vascular or hyper-vascular pattern will be recorded.
Measured: 6 months
Lesion borders (smooth or irregular)
Percentage of cases with smooth or irregular borders will be recorded.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start1 May 2016
- Primary completionMay 2018
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Pancreatic NeoplasmsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Francesco Crinò, MD, Azienda Ospedaliera Universitaria Integrata Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738280
- Sponsor's protocol ID
- 1296CESC
- Acronym
- LE-VASC
- Status last verified
- May 2019
- First submitted
- 8 Nov 2018
- Last updated
- 7 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of EUS in Differential Diagnosis and Malignancy Prediction of Non-hypovascular Solid Pancreatic Lesions: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03738280
- Acronym / sponsor ID
- LE-VASC / 1296CESC
- Conditions
- Solid Pancreatic Neoplasms, Endoscopic Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 13 Nov 2018 (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.
Vascular pattern of solid pancreatic lesions (SPLs) has been investigated by different abdominal imaging modalities and by contrast-enhanced endoscopic ultrasonography (CE-EUS). Compared with surrounding pancreatic parenchyma three different patterns have been described: hypo-, iso-, and hypervascular. The majority of SPLs are hypovascular, and the diagnostic relevance of hypoenhanced pattern to predict pancreatic adenocarcinoma (PDAC) is well established. Differently, iso- and hypervascular pattern is not specific and can be expressed by several SPLs, with different clinical behavior and management. To date, poor is know about the role of EUS in differential diagnosis of non-hypovascular SPLs and features associated with malignancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients fulfilling inclusion and exclusion criteria will be included in the study.
Key inclusion criteria (1 listed)
- Presence of one or more solid pancreatic lesions preliminary evaluated by contrast-enhanced computed tomography (CE-CT) and/or contrast enhanced magnetic resonance imaging (CE-MRI) reporting a non-hypovascular contrast pattern (e.g., iso- or hypervascular).
Key exclusion criteria (4 listed)
- Patients with associated chronic pancreatitis features (e.g., pancreatic calcifications)
- Lesion with hypovascular pattern at CE-EUS.
- Lesion not found or non pancreatic at EUS.
- Patients refusing to be included in the study
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 |
|---|---|---|
| Endoscopic ultrasound-fine needle biopsyPatients with non-hypovascular solid pancreatic lesion undergo endoscopic ultrasound-fine needle biopsy | Diagnostic test | – |
Primary outcome
Upstream dilation of the main pancreatic duct
Time frame: 6 months
Percentage of cases with upstream dilation of main pancreatic duct will be recorded.
Vascular pattern (iso or hypervascular)
Time frame: 6 months
Percentage of cases with iso-vascular or hyper-vascular pattern will be recorded.
Lesion borders (smooth or irregular)
Time frame: 6 months
Percentage of cases with smooth or irregular borders will be recorded.
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 7 May 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Pancreatic Neoplasms and Endoscopic Ultrasound, run by Azienda Ospedaliera Universitaria Integrata Verona 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 1 inclusion and 4 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 7 May 2019. 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?
Upstream dilation of the main pancreatic duct (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2019.