Pancreatic AdenocarcinomaREuBioNCT05226572
Repeated EUS-guided Fine Needle Biopsy of Pancreatic Masses After Non-diagnostic or Inconclusive Results
An observational study of Pancreatic Adenocarcinoma and Pancreas Cancer, run by University of Bologna at 1 site in Italy.
Trial summary
The primary aim of REuBio study is to evaluate the diagnostic accuracy of repeated endoscopic ultrasound-guided fine needle biopsy after a previous non-diagnostic or inconclusive EUS-guided sampling of solid pancreatic lesions. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pancreatic Adenocarcinoma, Pancreas Cancer, Pancreas Metastases
- What is being tested?
- endoscopic ultrasound-guided fine needle biopsy
- How many people
- 462 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2017to 23 May 2022
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A multicenter retrospective observational study enrolling all the consecutive patients who underwent a repeated EUS-guided tissue sampling for solid pancreatic masses with an EUS-FNB needle, after previous non-diagnostic or inconclusive result.
Who may be able to join
- Age >18 years old
- Solid pancreatic mass
- Previous non diagnostic or inconclusive EUS-tissue aquisition
Who cannot join
- age < 18 years old
- pancreatic mass with a predominantly cystic component
- previous pancreatic tissue acquisition was not performed under EUS-guidance (e.g. percutaneous sampling under abdominal ultrasound-guidance)
- repetition of pancreatic tissue sampling, after an inconclusive or non-diagnostic result, obtained by other methods than EUS-FNB, such as EUS-FNA or surgery or percutaneous sampling.
- patients with anatomic alterations or hematologic instability (including presence of severe blood clotting disorders) were excluded.
- rEUS-FNB of an extra-pancreatic mass
Trial locations and contacts
1 site in 1 country.
Italy1 site
Gastrointestinal Unit, University of Bologna/Hospital of Imola
Bologna, 40026
About this study
Official title: Repeated EUS-guided Fine Needle Biopsy of Pancreatic Masses After Non-diagnostic or Inconclusive Results - The REuBio Study
The primary aim of REuBio study is to evaluate the diagnostic accuracy of repeated endoscopic ultrasound-guided fine needle biopsy after a previous non-diagnostic or inconclusive EUS-guided sampling of solid pancreatic lesions.
Read the detailed description
Endoscopic ultrasound-guided fine needles biopsy (EUS-FNB) represents the gold standard method for the diagnosis of solid pancreatic lesions (SPLs), even if a non-negligible risk of false-negative or inconclusive results still exists.
In such cases, major guidelines recommend repeating EUS-guided tissue sampling. Nevertheless, this recommendation is not based on high-quality evidence and little is known about the performance of repeated EUS-FNB (rEUS-FNB).
The primary aim of this study is to evaluate the diagnostic accuracy of rEUS-FNB after a previous non-diagnostic or inconclusive EUS-guided sampling of SPLs.
The secondary aims of this study are to evaluate rEUS-FNB sensitivity, specificity, positive predictive value, negative predictive value, specimen adequacy, Bethesda classification, adverse events incidence and factors that influenced rEUS-FNB performance.
- Being tested
- endoscopic ultrasound-guided fine needle biopsy
- Keywords
- Endoscopic Ultrasound, EUS-FNB, Solid Pancreatic lesion
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic ultrasound-guided fine needle biopsyDiagnostic test
repeated endoscopic ultrasound-guided fine needle-biopsy after a previous non diagnostic or incoclusive endoscopic ultrasound-guided tissue aquisition for pancreatic solid lesions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield (%) of repeated EUS-fine needle biopsy of pancreatic masses after previous non-diagnostic or inconclusive results
Outcome was measured as percentage (%)
Measured: 5 years
Secondary outcomes (1)
Sensitivity (%), specificity(%), positive predictive value(%), negative predictive value(%), specimen adequacy(%), Bethesda classification, adverse events incidence (%) and factors that influenced repeated EUS-fine needle biopsy performance.
Outcome was measured as percentage (%)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start1 Jul 2017
- Primary completion23 May 2022
- Study completion23 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pietro Fusaroli, University of Bologna
- Investigators
- Pietro Fusaroli, Professor, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226572
- Sponsor's protocol ID
- IMO-01
- Acronym
- REuBio
- Status last verified
- Nov 2022
- First submitted
- 25 Jan 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated EUS-guided Fine Needle Biopsy of Pancreatic Masses After Non-diagnostic or Inconclusive Results - The REuBio Study
- ClinicalTrials.gov ID
- NCT05226572
- Acronym / sponsor ID
- REuBio / IMO-01
- Keywords
- Endoscopic Ultrasound, EUS-FNB, Solid Pancreatic lesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 23 May 2022 (actual)
- First posted
- 7 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 primary aim of REuBio study is to evaluate the diagnostic accuracy of repeated endoscopic ultrasound-guided fine needle biopsy after a previous non-diagnostic or inconclusive EUS-guided sampling of solid pancreatic lesions.
Detailed description
Endoscopic ultrasound-guided fine needles biopsy (EUS-FNB) represents the gold standard method for the diagnosis of solid pancreatic lesions (SPLs), even if a non-negligible risk of false-negative or inconclusive results still exists.
In such cases, major guidelines recommend repeating EUS-guided tissue sampling. Nevertheless, this recommendation is not based on high-quality evidence and little is known about the performance of repeated EUS-FNB (rEUS-FNB).
The primary aim of this study is to evaluate the diagnostic accuracy of rEUS-FNB after a previous non-diagnostic or inconclusive EUS-guided sampling of SPLs.
The secondary aims of this study are to evaluate rEUS-FNB sensitivity, specificity, positive predictive value, negative predictive value, specimen adequacy, Bethesda classification, adverse events incidence and factors that influenced rEUS-FNB performance.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A multicenter retrospective observational study enrolling all the consecutive patients who underwent a repeated EUS-guided tissue sampling for solid pancreatic masses with an EUS-FNB needle, after previous non-diagnostic or inconclusive result.
Key inclusion criteria (3 listed)
- Age >18 years old
- Solid pancreatic mass
- Previous non diagnostic or inconclusive EUS-tissue aquisition
Key exclusion criteria (6 listed)
- age < 18 years old
- pancreatic mass with a predominantly cystic component
- previous pancreatic tissue acquisition was not performed under EUS-guidance (e.g. percutaneous sampling under abdominal ultrasound-guidance)
- repetition of pancreatic tissue sampling, after an inconclusive or non-diagnostic result, obtained by other methods than EUS-FNB, such as EUS-FNA or surgery or percutaneous sampling.
- patients with anatomic alterations or hematologic instability (including presence of severe blood clotting disorders) were excluded.
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-guided fine needle biopsyrepeated endoscopic ultrasound-guided fine needle-biopsy after a previous non diagnostic or incoclusive endoscopic ultrasound-guided tissue aquisition for pancreatic solid lesions. | Diagnostic test | – |
Primary outcome
Diagnostic yield (%) of repeated EUS-fine needle biopsy of pancreatic masses after previous non-diagnostic or inconclusive results
Time frame: 5 years
Outcome was measured as percentage (%)
1 secondary outcome
Sensitivity (%), specificity(%), positive predictive value(%), negative predictive value(%), specimen adequacy(%), Bethesda classification, adverse events incidence (%) and factors that influenced repeated EUS-fine needle biopsy performance.
Time frame: 5 years
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 8 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
Pietro Fusaroli, Professor principal investigator
University of Bologna
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 Pancreatic Adenocarcinoma and Pancreas Cancer, run by University of Bologna 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 3 inclusion and 6 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 8 Nov 2022. 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?
Diagnostic yield (%) of repeated EUS-fine needle biopsy of pancreatic masses after previous non-diagnostic or inconclusive results (time frame: 5 years). 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 8 Nov 2022.