MedTrace Logo

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

NCT06315439 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 78

Last updated 2024-03-18

No results posted yet for this study

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.

Ex-vivo fluorescence confocal laser microscopy (FCM) with MAVIG VivaScope® 2500M-G4 could allow real time assessment of adequacy and diagnosis of the sample.

Conditions

  • Pancreas Adenocarcinoma
  • Endoscopic Ultrasound
  • Digital Pathology

Interventions

PROCEDURE

Endoscopic ultrasound fine needle biopsy

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.

Sponsors & Collaborators

  • Campus Bio-Medico University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-11-30
Completion
2023-11-30

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06315439 on ClinicalTrials.gov