Milena Di Leo1, Stefano Francesco Crinò2, Laura Bernardoni2, Daoud Rahal3, Francesco Auriemma4, Loredana Correale5, Giulio Donato6, Marco Massidda4, Andrea Anderloni4, Erminia Manfrin7, Elia Armellini6, Laura Poliani4, Alessandro Fugazza4, Rossella Semeraro4, Pietro Occhipinti6, Alessandro Repici1, Silvia Carrara8. 1. Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Research Hospital, Milan, Italy; Humanitas University, Department of Biomedical Sciences, Milan, Italy. 2. Gastroenterology and Digestive Endoscopy Unit, Pancreas Institute, G. B. Rossi University Hospital, Verona, Italy. 3. Pathological Department, Humanitas Research Hospital, Milan, Italy. 4. Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Research Hospital, Milan, Italy. 5. Centro di Prevenzione Oncologica, Turin, Italy. 6. Digestive Endoscopy Unit, Ospedale Maggiore della Carità, Novara, Italy. 7. Department of Diagnostics and Public Health, G. B. Rossi University Hospital, Verona, Italy. 8. Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Research Hospital, Milan, Italy. Electronic address: silvia.carrara@humanitas.it.
Abstract
BACKGROUND AND AIM: Endoscopic ultrasound-guided sampling (EUS sampling) is a safe and effective technique. The study aim was to evaluate the presence of a histological core from pancreatic lesions using a new 25G fork-tip needle. METHODS: Observational multicenter prospective and analytical study, including consecutive patients with solid pancreatic masses referred for EUS-guided sampling. At each needle pass, the endoscopist performed macroscopic on-site evaluation (MOSE). The primary outcome was the histological core procurement rates. Secondary outcomes were the evaluation of interobserver agreement between endoscopists and pathologists, adequacy of EUS samples for the diagnosis and post-procedure adverse events. RESULTS: 100 patients were enrolled in 3 centers. The mean size of the lesions was 28.5 mm (SD 11.7). Final diagnoses were adenocarcinoma (68%), neuroendocrine tumor (21%), inflammatory mass/benign lesions (8.0%), and pancreatic metastasis (3.0%). The pathologists described the presence of a core in 67 samples (67.0% of patients), with poor agreement with MOSE (kappa, 0. 12; 95% CI: 0.03-0.28). The diagnostic accuracy was 93%. We observed 6% of mild adverse events. CONCLUSION: The new 25-gauge core needle showed good overall adequacy and a good rate of histological specimens during EUS sampling of solid pancreatic masses, with a minimum number of passes and no major complications. Clinicaltrial.gov number, NCT02946840.
BACKGROUND AND AIM: Endoscopic ultrasound-guided sampling (EUS sampling) is a safe and effective technique. The study aim was to evaluate the presence of a histological core from pancreatic lesions using a new 25G fork-tip needle. METHODS: Observational multicenter prospective and analytical study, including consecutive patients with solid pancreatic masses referred for EUS-guided sampling. At each needle pass, the endoscopist performed macroscopic on-site evaluation (MOSE). The primary outcome was the histological core procurement rates. Secondary outcomes were the evaluation of interobserver agreement between endoscopists and pathologists, adequacy of EUS samples for the diagnosis and post-procedure adverse events. RESULTS: 100 patients were enrolled in 3 centers. The mean size of the lesions was 28.5 mm (SD 11.7). Final diagnoses were adenocarcinoma (68%), neuroendocrine tumor (21%), inflammatory mass/benign lesions (8.0%), and pancreatic metastasis (3.0%). The pathologists described the presence of a core in 67 samples (67.0% of patients), with poor agreement with MOSE (kappa, 0. 12; 95% CI: 0.03-0.28). The diagnostic accuracy was 93%. We observed 6% of mild adverse events. CONCLUSION: The new 25-gauge core needle showed good overall adequacy and a good rate of histological specimens during EUS sampling of solid pancreatic masses, with a minimum number of passes and no major complications. Clinicaltrial.gov number, NCT02946840.
Authors: Diogo T H de Moura; Thomas R McCarty; Pichamol Jirapinyo; Igor B Ribeiro; Kelly E Hathorn; Antonio Coutinho Madruga-Neto; Linda S Lee; Christopher C Thompson Journal: Endosc Int Open Date: 2020-05-25