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

Stefano Francesco Crino, Stefano Partelli, Bertrand Napoleon, Maria Cristina Conti Bellocchi, Antonio Facciorusso, Roberto Salvia, Edoardo Forti, Marcello Cintolo, Michele Mazzola, Giovanni Ferrari, et al.
(2023) DIGESTIVE AND LIVER DISEASE. 55(9). p.1187-1193
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Abstract
Background: 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. Aims: 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. Methods: 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. Discussion: 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. & COPY; 2023 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
Keywords
Endoscopic ultrasound, Neuroendocrine tumors, Pancreatic fistula, Acute pancreatitis, Hypoglicemia, Insulin, INTERNATIONAL STUDY-GROUP, ENETS CONSENSUS GUIDELINES, NEUROENDOCRINE TUMORS, ADVERSE EVENTS, MANAGEMENT, CLASSIFICATION, DEFINITION, NEOPLASMS, COMPLICATIONS, SURGERY

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Citation

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MLA
Crino, Stefano Francesco, et al. “Study Protocol for a Multicenter Randomized Controlled Trial to Compare Radiofrequency Ablation with Surgical Resection for Treatment of Pancreatic Insulinoma.” DIGESTIVE AND LIVER DISEASE, vol. 55, no. 9, 2023, pp. 1187–93, doi:10.1016/j.dld.2023.06.021.
APA
Crino, S. F., Partelli, S., Napoleon, B., Bellocchi, M. C. C., Facciorusso, A., Salvia, R., … Landoni, L. (2023). Study protocol for a multicenter randomized controlled trial to compare radiofrequency ablation with surgical resection for treatment of pancreatic insulinoma. DIGESTIVE AND LIVER DISEASE, 55(9), 1187–1193. https://doi.org/10.1016/j.dld.2023.06.021
Chicago author-date
Crino, Stefano Francesco, Stefano Partelli, Bertrand Napoleon, Maria Cristina Conti Bellocchi, Antonio Facciorusso, Roberto Salvia, Edoardo Forti, et al. 2023. “Study Protocol for a Multicenter Randomized Controlled Trial to Compare Radiofrequency Ablation with Surgical Resection for Treatment of Pancreatic Insulinoma.” DIGESTIVE AND LIVER DISEASE 55 (9): 1187–93. https://doi.org/10.1016/j.dld.2023.06.021.
Chicago author-date (all authors)
Crino, Stefano Francesco, Stefano Partelli, Bertrand Napoleon, Maria Cristina Conti Bellocchi, Antonio Facciorusso, Roberto Salvia, Edoardo Forti, Marcello Cintolo, Michele Mazzola, Giovanni Ferrari, Silvia Carrara, Alessandro Repici, Alessandro Zerbi, Andrea Lania, Matteo Tacelli, Paolo Giorgio Arcidiacono, Massimo Falconi, Alberto Larghi, Gianenrico Rizzatti, Sergio Alfieri, Francesco Panzuto, Pieter Hindryckx, Frederik Berrevoet, Bruno Lapauw, Sundeep Lakhtakia, Sridhar Sundaram, Jayanta Samanta, Ashu Rastogi, and Luca Landoni. 2023. “Study Protocol for a Multicenter Randomized Controlled Trial to Compare Radiofrequency Ablation with Surgical Resection for Treatment of Pancreatic Insulinoma.” DIGESTIVE AND LIVER DISEASE 55 (9): 1187–1193. doi:10.1016/j.dld.2023.06.021.
Vancouver
1.
Crino SF, Partelli S, Napoleon B, Bellocchi MCC, Facciorusso A, Salvia R, et al. Study protocol for a multicenter randomized controlled trial to compare radiofrequency ablation with surgical resection for treatment of pancreatic insulinoma. DIGESTIVE AND LIVER DISEASE. 2023;55(9):1187–93.
IEEE
[1]
S. F. Crino et al., “Study protocol for a multicenter randomized controlled trial to compare radiofrequency ablation with surgical resection for treatment of pancreatic insulinoma,” DIGESTIVE AND LIVER DISEASE, vol. 55, no. 9, pp. 1187–1193, 2023.
@article{01J0V17NY48PX2JV7ZTYWAF7YT,
  abstract     = {{Background: 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. Aims: 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. Methods: 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. Discussion: 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. & COPY; 2023 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.}},
  author       = {{Crino, Stefano Francesco and  Partelli, Stefano and  Napoleon, Bertrand and  Bellocchi, Maria Cristina Conti and  Facciorusso, Antonio and  Salvia, Roberto and  Forti, Edoardo and  Cintolo, Marcello and  Mazzola, Michele and  Ferrari, Giovanni and  Carrara, Silvia and  Repici, Alessandro and  Zerbi, Alessandro and  Lania, Andrea and  Tacelli, Matteo and  Arcidiacono, Paolo Giorgio and  Falconi, Massimo and  Larghi, Alberto and  Rizzatti, Gianenrico and  Alfieri, Sergio and  Panzuto, Francesco and Hindryckx, Pieter and Berrevoet, Frederik and Lapauw, Bruno and  Lakhtakia, Sundeep and  Sundaram, Sridhar and  Samanta, Jayanta and  Rastogi, Ashu and  Landoni, Luca}},
  issn         = {{1590-8658}},
  journal      = {{DIGESTIVE AND LIVER DISEASE}},
  keywords     = {{Endoscopic ultrasound,Neuroendocrine tumors,Pancreatic fistula,Acute pancreatitis,Hypoglicemia,Insulin,INTERNATIONAL STUDY-GROUP,ENETS CONSENSUS GUIDELINES,NEUROENDOCRINE TUMORS,ADVERSE EVENTS,MANAGEMENT,CLASSIFICATION,DEFINITION,NEOPLASMS,COMPLICATIONS,SURGERY}},
  language     = {{eng}},
  number       = {{9}},
  pages        = {{1187--1193}},
  title        = {{Study protocol for a multicenter randomized controlled trial to compare radiofrequency ablation with surgical resection for treatment of pancreatic insulinoma}},
  url          = {{http://doi.org/10.1016/j.dld.2023.06.021}},
  volume       = {{55}},
  year         = {{2023}},
}
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