Pancreas Adenocarcinoma Clinical Trial
— Multi-RELAMIOfficial title:
Digital Confocal Microscopy for Real-time Diagnosis of Pancreatic Solid Lesion: a Multicentre Study
Verified date | March 2024 |
Source | Campus Bio-Medico University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 78 |
Est. completion date | November 30, 2023 |
Est. primary completion date | November 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - pancreatic solid lesions Exclusion Criteria: - cystic lesions - not suitable acoustic window for needle biopsy - decline to give informed consent. |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione Policlinico Campus Bio Medico | Rome | Roma |
Lead Sponsor | Collaborator |
---|---|
Campus Bio-Medico University |
Italy,
Facciorusso 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. — View Citation
Gkolfakis 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. — View Citation
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. — View Citation
Polkowski 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. — View Citation
Stigliano 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | baseline |
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