Digital Confocal Microscopy for Real-time Diagnosis of Pancreatic Solid Lesion

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.

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Key information

Conditions

Pancreas Adenocarcinoma Digital Pathology Endoscopic Ultrasound

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Campus Bio Medico

Rome, ROMA, 00191, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

pancreatic solid lesions

Exclusion criteria

cystic lesions
not suitable acoustic window for needle biopsy
decline to give informed consent.

Treatment and study plan

Endoscopic ultrasound fine needle biopsy

Procedure

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

Digital Confocal Microscopy for Real-time Diagnosis of Pancreatic Solid Lesion: a Multicentre Study

Acronym: Multi-RELAMI

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Mar 18, 2024
Registry last updated: Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed