Clinical Trial: Needle-based Confocal Laser Endomicroscopy on Pancreatic Cystic Lesions

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Clinical Impact of Needle-based Confocal Laser Endomicroscopy of Cystic Pancreatic Lesions

Brief Summary: 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.

Detailed Summary:

Clinical Impact of Needle-based Confocal Laser Endomicroscopy of Cystic Pancreatic Lesions (CINE-Cyst)

Background The diagnostic evaluation of cystic pancreatic lesions represents a difficult problem for clinical decision making, due to the increased incidental discovery of such lesions during cross-sectional imaging (computed tomography or magnetic resonance). Prevalence of cystic pancreatic lesions is estimated between 2 to 20% in the adult population (1-3), while autopsy studies show that the prevalence increases with age (4). The WHO classification (revised in 2010) reported several categories, with serous cystadenoma (SCA), mucinous cystic neoplasms (MCN), intraductal papillary mucinous neoplasms (IPMN) and pseudopapillary neoplasms representing more than 90% (5). Several of these lesions progress to cystadenocarcinoma (with the notable exception of SCA), hence the differential diagnosis is extremely important for the clinical decisions that currently involve either imaging follow-up (usually based on EUS and magnetic resonance imaging [MRI]) or referral to surgery with a final pathological diagnosis established after resection.

Nevertheless, there is considerable overlap in the imaging characteristics of benign, premalignant or malignant pancreatic cysts which leads to unclear clinical management algorithms. Several international guidelines addressed the diagnosis and management of cystic pancreatic lesions (6-8). The most comprehensive guideline reported a clinical decision algorithm which included clinical and imaging criteria, like pancreatitis / jaundice or cyst size > 3 cm, thickening / enhancing cyst walls, main pancreatic duct (MPD) size 5-9 mm, non-enhancing mural nodules and abrupt changes in the caliber of pancreatic duct with distal pancreatic atrophy [8]. If any of these clinical / imaging characterist
Sponsor: University of Medicine and Pharmacy Craiova

Current Primary Outcome: Accuracy of EUS-guided nCLE in a cohort of cystic pancreatic tumors [ Time Frame: 6 months ]

Final diagnosis reached by surgical pathology and/or follow-up


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of participants with adverse events as a measure of safety [ Time Frame: 1 month ]

Adverse events like acute pancreatitis, cyst infection, etc.


Original Secondary Outcome: Same as current

Information By: University of Medicine and Pharmacy Craiova

Dates:
Date Received: June 23, 2015
Date Started: June 2015
Date Completion: June 2017
Last Updated: July 9, 2015
Last Verified: July 2015