Pancreas AdenocarcinomaMulti-RELAMINCT06315439
Digital Confocal Microscopy for Real-time Diagnosis of Pancreatic Solid Lesion
An observational study of Pancreas Adenocarcinoma and Endoscopic Ultrasound, run by Campus Bio-Medico University at 1 site in Italy.
Trial summary
Endoscopic ultrasound-guided (EUS) tissue acquisition is the current standard of care for the diagnosis of pancreatic solid lesions but it is burdened by a non-negligible risk of non-diagnostic or inconclusive results. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pancreas Adenocarcinoma, Endoscopic Ultrasound, Digital Pathology
- What is being tested?
- Endoscopic ultrasound fine needle biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 78 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2023to 30 Nov 2023
- How long will I take part?
- 1 Day
- 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: Patients with solid pancreatic lesion will be enrolled
Who may be able to join
- pancreatic solid lesions
Who cannot join
- cystic lesions
- not suitable acoustic window for needle biopsy
- decline to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Confocal Microscopy for Real-time Diagnosis of Pancreatic Solid Lesion: a Multicentre Study
Endoscopic ultrasound-guided (EUS) tissue acquisition is the current standard of care for the diagnosis of pancreatic solid lesions but it is burdened by a non-negligible risk of non-diagnostic or inconclusive results.
Ex-vivo fluorescence confocal laser microscopy (FCM) with MAVIG VivaScope® 2500M-G4 could allow real time assessment of adequacy and diagnosis of the sample.
Read the detailed description
Endoscopic ultrasound-guided (EUS) tissue acquisition is the current standard of care for the diagnosis of pancreatic solid lesions.
However, EUS-sampling is burdened by a non-negligible risk of non-diagnostic or inconclusive results, with an estimated negative predictive value not higher than 70-80%.
ROSE could improve the diagnostic yeld of this procedure. Data about the utility of rapid on-site evalutation (ROSE) are still controversial. Without ROSE, current guidelines suggest performance of three to four needle passes with an fine needle aspiration (FNA) needle or two to three passes with a fine needle biopsy (FNB) needle.
Potential drawbacks of ROSE are the considerable time commitment, costs and logistical and personnel issues that arise because of the "on demand" nature of these procedures with the need to have available technologists.
Ex-vivo fluorescence confocal laser microscopy (FCM) is an optical technology for rapid microscopic digital imaging of fresh unfixed biological specimens without any slide preparation.
FCM involves no damage or cell/tissue loss during the examination and the sample can subsequently be recovered and formalin-fixed and paraffin-embedded (FFPE) for permanent histology. FCM allows both cellular and architectural details to be visualized, similar to standard histological analysis of paraffin-embedded or frozen samples. With FCM, multimodal confocal microscopy using different laser sources and fusion images can generate optical plans similar to those from hematoxylin/eosin (H\&E)- stained sections directly from native tissues.
Recently, the feasibility of FCM with MAVIG VivaScope® 2500M-G4 in EUS-FNB sample of pancreatic solid lesions has been investigated . This previous single-center study demonstrated good concordance between the FCM image-based evaluation and the final FFPE histology.
However in this first study, a single type of FNB needle was used for all the procedures and the pathologist involved was expert in digital pathology and in pancreatic disease. Therefore it might be not representative of the everyday clinical practice. In addition the first study was mainly focused on the adequacy assessment of the samples.
- 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 biopsyProcedure or surgery
EUS FNA/B for solid pancreatic lesions. After the FNA/FNB, the needle was removed from the EUS endoscope and the specimen obtained after the first needle pass was expelled and placed directly in a dedicated scaffold (Cytomatrix, UCS Diagnostics).
a drop of ethanol was put on it and the liquid was drained away thanks to the porous structure of the matrix. This step was followed by the deposition of a drop of acridine-orange for 20" and a rapid washing with buffered saline. After that, the Cytomatrix was put on a dedicated microscopic slide and covered with a second slide before the introduction in the slot of the machine.
The FCM VivaScope® 2500 (2500M-G4; VivaScope, Munich, Germany) was used for immediate imaging.
| Study group | Role | What they receive |
|---|---|---|
| pancreatic solid lesions | Not described Receives: Procedure: Endoscopic ultrasound fine needle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
To evaluate the accuracy of fluorescence confocal microscopy (FCM) for ex-vivo examination of samples obtained from EUS- FNA/B in pancreatic solid lesions to assess final diagnosis against final histological diagnosis.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Jan 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pancreas 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Maria Di Matteo, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315439
- Sponsor's protocol ID
- Multi-RELAMI
- Acronym
- Multi-RELAMI
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Itoi T, Sofuni A, Itokawa F, Irisawa A, Khor CJ, Rerknimitr R. Current status of diagnostic endoscopic ultrasonography in the evaluation of pancreatic mass lesions. Dig Endosc. 2011 May;23 Suppl 1:17-21. doi: 10.1111/j.1443-1661.2011.01132.x.
PubMed 21535194Polkowski M, Jenssen C, Kaye P, Carrara S, Deprez P, Gines A, Fernandez-Esparrach G, Eisendrath P, Aithal GP, Arcidiacono P, Barthet M, Bastos P, Fornelli A, Napoleon B, Iglesias-Garcia J, Seicean A, Larghi A, Hassan C, van Hooft JE, Dumonceau JM. Technical aspects of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Guideline - March 2017. Endoscopy. 2017 Oct;49(10):989-1006. doi: 10.1055/s-0043-119219. Epub 2017 Sep 12.
PubMed 28898917Facciorusso A, Wani S, Triantafyllou K, Tziatzios G, Cannizzaro R, Muscatiello N, Singh S. Comparative accuracy of needle sizes and designs for EUS tissue sampling of solid pancreatic masses: a network meta-analysis. Gastrointest Endosc. 2019 Dec;90(6):893-903.e7. doi: 10.1016/j.gie.2019.07.009. Epub 2019 Jul 13.
PubMed 31310744Gkolfakis P, Crino SF, Tziatzios G, Ramai D, Papaefthymiou A, Papanikolaou IS, Triantafyllou K, Arvanitakis M, Lisotti A, Fusaroli P, Mangiavillano B, Carrara S, Repici A, Hassan C, Facciorusso A. Comparative diagnostic performance of end-cutting fine-needle biopsy needles for EUS tissue sampling of solid pancreatic masses: a network meta-analysis. Gastrointest Endosc. 2022 Jun;95(6):1067-1077.e15. doi: 10.1016/j.gie.2022.01.019. Epub 2022 Feb 4.
PubMed 35124072Stigliano S, Crescenzi A, Taffon C, Covotta F, Hassan C, Antonelli G, Verri M, Biasutto D, Scarpa RM, Di Matteo FM. Role of fluorescence confocal microscopy for rapid evaluation of EUS fine-needle biopsy sampling in pancreatic solid lesions. Gastrointest Endosc. 2021 Sep;94(3):562-568.e1. doi: 10.1016/j.gie.2021.03.029. Epub 2021 Mar 31.
PubMed 33798539
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Confocal Microscopy for Real-time Diagnosis of Pancreatic Solid Lesion: a Multicentre Study
- ClinicalTrials.gov ID
- NCT06315439
- Acronym / sponsor ID
- Multi-RELAMI / Multi-RELAMI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 18 Mar 2024 (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.
Endoscopic ultrasound-guided (EUS) tissue acquisition is the current standard of care for the diagnosis of pancreatic solid lesions but it is burdened by a non-negligible risk of non-diagnostic or inconclusive results.
Ex-vivo fluorescence confocal laser microscopy (FCM) with MAVIG VivaScope® 2500M-G4 could allow real time assessment of adequacy and diagnosis of the sample.
Detailed description
Endoscopic ultrasound-guided (EUS) tissue acquisition is the current standard of care for the diagnosis of pancreatic solid lesions.
However, EUS-sampling is burdened by a non-negligible risk of non-diagnostic or inconclusive results, with an estimated negative predictive value not higher than 70-80%.
ROSE could improve the diagnostic yeld of this procedure. Data about the utility of rapid on-site evalutation (ROSE) are still controversial. Without ROSE, current guidelines suggest performance of three to four needle passes with an fine needle aspiration (FNA) needle or two to three passes with a fine needle biopsy (FNB) needle.
Potential drawbacks of ROSE are the considerable time commitment, costs and logistical and personnel issues that arise because of the "on demand" nature of these procedures with the need to have available technologists.
Ex-vivo fluorescence confocal laser microscopy (FCM) is an optical technology for rapid microscopic digital imaging of fresh unfixed biological specimens without any slide preparation.
FCM involves no damage or cell/tissue loss during the examination and the sample can subsequently be recovered and formalin-fixed and paraffin-embedded (FFPE) for permanent histology. FCM allows both cellular and architectural details to be visualized, similar to standard histological analysis of paraffin-embedded or frozen samples. With FCM, multimodal confocal microscopy using different laser sources and fusion images can generate optical plans similar to those from hematoxylin/eosin (H\&E)- stained sections directly from native tissues.
Recently, the feasibility of FCM with MAVIG VivaScope® 2500M-G4 in EUS-FNB sample of pancreatic solid lesions has been investigated . This previous single-center study demonstrated good concordance between the FCM image-based evaluation and the final FFPE histology.
However in this first study, a single type of FNB needle was used for all the procedures and the pathologist involved was expert in digital pathology and in pancreatic disease. Therefore it might be not representative of the everyday clinical practice. In addition the first study was mainly focused on the adequacy assessment of the samples.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pancreatic solid lesions | – | Procedure: Endoscopic ultrasound fine needle biopsy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with solid pancreatic lesion will be enrolled
Key inclusion criteria (1 listed)
- pancreatic solid lesions
Key exclusion criteria (3 listed)
- cystic lesions
- not suitable acoustic window for needle biopsy
- decline to give informed consent.
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 biopsyEUS FNA/B for solid pancreatic lesions. After the FNA/FNB, the needle was removed from the EUS endoscope and the specimen obtained after the first needle pass was expelled and placed directly in a dedicated scaffold (Cytomatrix, UCS Diagnostics). a drop of ethanol was put on it and the liquid was drained away thanks to the porous structure of the matrix. This step was followed by the deposition of a drop of acridine-orange for 20" and a rapid washing with buffered saline. After that, the Cytomatrix was put on a dedicated microscopic slide and covered with a second slide before the introduction in the slot of the machine. The FCM VivaScope® 2500 (2500M-G4; VivaScope, Munich, Germany) was used for immediate imaging. | Procedure or surgery | pancreatic solid lesions |
Primary outcome
Diagnostic accuracy
Time frame: baseline
To evaluate the accuracy of fluorescence confocal microscopy (FCM) for ex-vivo examination of samples obtained from EUS- FNA/B in pancreatic solid lesions to assess final diagnosis against final histological diagnosis.
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 18 Mar 2024.
- Background: PubMed 21535194Itoi T, Sofuni A, Itokawa F, Irisawa A, Khor CJ, Rerknimitr R. Current status of diagnostic endoscopic ultrasonography in the evaluation of pancreatic mass lesions. Dig Endosc. 2011 May;23 Suppl 1:17-21. doi: 10.1111/j.1443-1661.2011.01132.x.
- Background: PubMed 28898917Polkowski M, Jenssen C, Kaye P, Carrara S, Deprez P, Gines A, Fernandez-Esparrach G, Eisendrath P, Aithal GP, Arcidiacono P, Barthet M, Bastos P, Fornelli A, Napoleon B, Iglesias-Garcia J, Seicean A, Larghi A, Hassan C, van Hooft JE, Dumonceau JM. Technical aspects of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Guideline - March 2017. Endoscopy. 2017 Oct;49(10):989-1006. doi: 10.1055/s-0043-119219. Epub 2017 Sep 12.
- Background: PubMed 31310744Facciorusso A, Wani S, Triantafyllou K, Tziatzios G, Cannizzaro R, Muscatiello N, Singh S. Comparative accuracy of needle sizes and designs for EUS tissue sampling of solid pancreatic masses: a network meta-analysis. Gastrointest Endosc. 2019 Dec;90(6):893-903.e7. doi: 10.1016/j.gie.2019.07.009. Epub 2019 Jul 13.
- Background: PubMed 35124072Gkolfakis P, Crino SF, Tziatzios G, Ramai D, Papaefthymiou A, Papanikolaou IS, Triantafyllou K, Arvanitakis M, Lisotti A, Fusaroli P, Mangiavillano B, Carrara S, Repici A, Hassan C, Facciorusso A. Comparative diagnostic performance of end-cutting fine-needle biopsy needles for EUS tissue sampling of solid pancreatic masses: a network meta-analysis. Gastrointest Endosc. 2022 Jun;95(6):1067-1077.e15. doi: 10.1016/j.gie.2022.01.019. Epub 2022 Feb 4.
- Background: PubMed 33798539Stigliano S, Crescenzi A, Taffon C, Covotta F, Hassan C, Antonelli G, Verri M, Biasutto D, Scarpa RM, Di Matteo FM. Role of fluorescence confocal microscopy for rapid evaluation of EUS fine-needle biopsy sampling in pancreatic solid lesions. Gastrointest Endosc. 2021 Sep;94(3):562-568.e1. doi: 10.1016/j.gie.2021.03.029. Epub 2021 Mar 31.
- 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 Pancreas Adenocarcinoma and Endoscopic Ultrasound, run by Campus Bio-Medico University 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 3 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 18 Mar 2024. 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 accuracy (time frame: baseline). 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 NCT06315439, which also lists 5 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 18 Mar 2024.