Needle-based Confocal Laser Endomicroscopy on Pancreatic Cystic Lesions

The study is based on a multi-center approach of needle based confocal laser endomicroscopy (nCLE) combined with endoscopic ultrasound (EUS) and EUS-guided fine needle aspiration (FNA) to evaluate pancreatic cystic lesions (PCL), in order to obtain a correct histopathological diagnosis.After detection of PCL, certain morphological EUS features allow the discrimination of specific cyst types. Additionally, EUS-FNA is recommended as the first-line procedure whenever pathological diagnosis is required; however the procedure has its drawbacks, mainly represented by the relatively low negative predictive value in diagnosing pancreatic cancer. In this case a more precisely diagnostic tool is required; the potential role of CLE has been explored in gastrointestinal (GI) pathology showing good accuracy for predicting the final histopathological diagnosis based on immediate evaluation of tissue and vascular patterns. Although the clinical impact of nCLE for the decision making algorithms in cystic pancreatic neoplasm has not yet been described, the hypothesis is that EUS-nCLE could allow targeted tissue sampling of cystic pancreatic neoplasms resulting in more accurate diagnosis. The aim of the study is to describe the clinical impact of nCLE for the clinical decision management algorithm based on EUS, EUS-FNA and/or EUS-CLE imaging criteria for cystic pancreatic neoplasms, while evaluating also the feasibility and safety of nCLE examination.

Sex

All

Minimum age

18 Years

Inclusion criteria:

* Age \> 18 years old, male or female
* Patients diagnosed with cystic pancreatic lesions with an indication for EUS-FNA
* Signed informed consent for EUS, EUS-FNA and EUS-nCLE performed during a single examination under sedation.

Exclusion criteria:

* Failure to provide informed consent
* Patients with a contraindication for EUS-FNA
* Known allergy to fluorescein
* Pregnant or breast-feeding patients

Data collected for each participant will include:

* Personal data (name, surname, age, sex)
* EUS variables (tumor characteristics)
* EUS-FNA results, including CEA, CA19-9, amylase levels
* EUS-nCLE images (suggestive images) and movies, digitally recorded and de-identified
* Histological and immunohistochemical findings (final diagnosis)