Study protocol for a multicenter randomized controlled trial to compare radiofrequency ablation with surgical resection for treatment of pancreatic insulinoma

• DOI: 10.1016/j.dld.2023.06.021
• Publication Date: 2023-07-03T11:54:24Z
• Authors: Stefano Francesco...; Stefano Partelli; Bertrand Napoleon; Maria Cristina Co...; Antonio Facciorusso; Roberto Salvia; Edoardo Forti; Marcello Cintolo; Michele Mazzola; Giovanni Ferrari; Silvia Carrara; Alessandro Repici; Alessandro Zerbi; Andrea Lania; Matteo Tacelli; Paolo Giorgio Arc...; Massimo Falconi; Alberto Larghi; Gianenrico Rizzatti; Sergio Alfieri; Francesco Panzuto; Pieter Hindryckx; Frederik Berrevoet; Bruno Lapauw; Sundeep Lakhtakia; Sridhar Sundaram; Jayanta Samanta; Ashu Rastogi; Luca Landoni
• Keywords: Hypoglicemia; SURGERY; INTERNATIONAL STUDY-GROUP; ENETS CONSENSUS GUIDELINES; CLASSIFICATION; Endosonography; Neuroendocrine tumor; Medicine and Health Sciences; MANAGEMENT; Insulin; Humans; Multicenter Studies as Topic; Acute pancreatiti; Randomized Controlled Trials as Topic; COMPLICATIONS; Radiofrequency Ablation; Endoscopic ultrasound; 3. Good health; Acute pancreatitis; Pancreatic Neoplasms; DEFINITION; Quality of Life; Insulinoma; Neuroendocrine tumors; ADVERSE EVENTS; acute pancreatitis; endoscopic ultrasound; hypoglicemia; insulin; neuroendocrine tumors; pancreatic fistula; NEUROENDOCRINE TUMORS; Pancreatic fistula; NEOPLASMS

Insulinoma is the most common functional pancreatic neuroendocrine tumor and treatment is required to address symptoms associated with insulin hypersecretion. Surgical resection is effective but burdened by high rate of adverse events (AEs). Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) demonstrated encouraging results in terms of safety and efficacy for the management of these tumors. However, studies comparing surgery and EUS-RFA are lacking.The primary aim is to compare EUS-RFA with surgery in term of safety (overall rate of AEs). Secondary endpoints include: (a) severe AEs rate; (b) clinical effectiveness; (c) patient's quality of life; (d) length of hospital stay; (e) rate of local/distance recurrence; (f) need of reintervention; (g) rate of endocrine and exocrine pancreatic insufficiency; (h) factors associated with EUS-RFA related AEs and clinical effectiveness.ERASIN-RCT is an international randomized superiority ongoing trial in four countries. Sixty patients will be randomized in two arms (EUS-RFA vs surgery) and outcomes compared. Two EUS-RFA sessions will be allowed to achieve symptoms resolution. Randomization and data collection will be performed online.This study will ascertain if EUS-RFA can become the first-line therapy for management of small, sporadic, pancreatic insulinoma and be included in a step-up approach in case of clinical failure.