The GENTLENESS study is a prospective, multicenter, observational registry designed to evaluate the endoscopic management of patients with suspected biliopancreatic and periampullary neoplastic diseases within the Pancreas Units network of the Lombardy Region.
Patients undergoing endoscopic ultrasound (EUS) for suspected pancreatic or periampullary malignancies, including pancreatic ductal adenocarcinoma, pancreatic neuroendocrine tumors, cystic pancreatic neoplasms requiring endoscopic, surgical, or oncological management, and periampullary tumors of the distal bile duct, ampulla, or duodenum, will be prospectively enrolled according to standard clinical practice.
The study aims to assess the diagnostic accuracy of EUS-guided tissue acquisition, procedural safety, the need for repeat sampling, and organizational performance indicators, including time to definitive cyto-histological diagnosis and time to initiation of disease-specific treatment. No additional procedures beyond routine clinical care will be performed as a result of study participation.