PMID- 37407318
OWN - NLM
STAT- MEDLINE
DCOM- 20230828
LR  - 20231003
IS  - 1878-3562 (Electronic)
IS  - 1590-8658 (Linking)
VI  - 55
IP  - 9
DP  - 2023 Sep
TI  - Study protocol for a multicenter randomized controlled trial to compare 
      radiofrequency ablation with surgical resection for treatment of pancreatic 
      insulinoma.
PG  - 1187-1193
LID - S1590-8658(23)00719-3 [pii]
LID - 10.1016/j.dld.2023.06.021 [doi]
AB  - 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.
CI  - Copyright (c) 2023 Editrice Gastroenterologica Italiana S.r.l. Published by 
      Elsevier Ltd. All rights reserved.
FAU - Crino, Stefano Francesco
AU  - Crino SF
AD  - Digestive Endoscopy Unit, The Pancreas Institute, G. B. Rossi University 
      Hospital, University Hospital of Verona, P.le L.A. Scuro 10, Verona 37134, Italy. 
      Electronic address: stefanofrancesco.crino@aovr.veneto.it.
FAU - Partelli, Stefano
AU  - Partelli S
AD  - Pancreatic and Transplant Surgery Unit, Pancreas Translational and Clinical 
      Research Centre, San Raffaele IRCCS, Universita Vita-Salute, Milan, Italy.
FAU - Napoleon, Bertrand
AU  - Napoleon B
AD  - Service de Gastroenterologie, Hopital Prive Jean Mermoz, Ramsay Generale de 
      Sante, Lyon, France.
FAU - Conti Bellocchi, Maria Cristina
AU  - Conti Bellocchi MC
AD  - Digestive Endoscopy Unit, The Pancreas Institute, G. B. Rossi University 
      Hospital, University Hospital of Verona, P.le L.A. Scuro 10, Verona 37134, Italy.
FAU - Facciorusso, Antonio
AU  - Facciorusso A
AD  - Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.
FAU - Salvia, Roberto
AU  - Salvia R
AD  - General and Pancreatic Surgery Department, Pancreas Institute, University of 
      Verona Hospital Trust, Verona, Italy.
FAU - Forti, Edoardo
AU  - Forti E
AD  - Digestive and Interventional Endoscopy Unit, ASST Niguarda, Milan, Italy.
FAU - Cintolo, Marcello
AU  - Cintolo M
AD  - Digestive and Interventional Endoscopy Unit, ASST Niguarda, Milan, Italy.
FAU - Mazzola, Michele
AU  - Mazzola M
AD  - Division of Minimally-Invasive Surgical Oncology, ASST Niguarda, Milan, Italy.
FAU - Ferrari, Giovanni
AU  - Ferrari G
AD  - Division of Minimally-Invasive Surgical Oncology, ASST Niguarda, Milan, Italy.
FAU - Carrara, Silvia
AU  - Carrara S
AD  - Division of Gastroenterology and Digestive Endoscopy, Humanitas Research 
      Hospital-IRCCS, Rozzano, MI, Italy.
FAU - Repici, Alessandro
AU  - Repici A
AD  - Division of Gastroenterology and Digestive Endoscopy, Humanitas Research 
      Hospital-IRCCS, Rozzano, MI, Italy.
FAU - Zerbi, Alessandro
AU  - Zerbi A
AD  - Pancreatic Unit, Humanitas Research Hospital-IRCCS, Rozzano, MI, Italy.
FAU - Lania, Andrea
AU  - Lania A
AD  - Endocrinology, Diabetology and Medical Andrology Unit, Humanitas Research 
      Hospital-IRCCS, Rozzano (MI), Italy.
FAU - Tacelli, Matteo
AU  - Tacelli M
AD  - Pancreato-Biliary Endoscopy and EUS Division, IRCCS San Raffaele Scientific 
      Institute, Vita-Salute San Raffaele University, Milan, Italy.
FAU - Arcidiacono, Paolo Giorgio
AU  - Arcidiacono PG
AD  - Pancreato-Biliary Endoscopy and EUS Division, IRCCS San Raffaele Scientific 
      Institute, Vita-Salute San Raffaele University, Milan, Italy.
FAU - Falconi, Massimo
AU  - Falconi M
AD  - Pancreatic and Transplant Surgery Unit, Pancreas Translational and Clinical 
      Research Centre, San Raffaele IRCCS, Universita Vita-Salute, Milan, Italy.
FAU - Larghi, Alberto
AU  - Larghi A
AD  - Digestive Endoscopy Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, 
      Rome, Italy.
FAU - Rizzatti, Gianenrico
AU  - Rizzatti G
AD  - Digestive Endoscopy Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, 
      Rome, Italy.
FAU - Alfieri, Sergio
AU  - Alfieri S
AD  - Pancreatic Surgery Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, 
      Rome, Italy.
FAU - Panzuto, Francesco
AU  - Panzuto F
AD  - Department of Medical-Surgical Sciences and Translational Medicine, Digestive 
      Disease Unit, ENETS Center of Excellence, Sant'Andrea University Hospital, 
      Sapienza University of Rome, Rome, Italy.
FAU - Hindryckx, Pieter
AU  - Hindryckx P
AD  - Department of Gastroenterology, University of Ghent, Ghent, Belgium.
FAU - Berrevoet, Frederik
AU  - Berrevoet F
AD  - Department of Hepatobiliopancreatic Surgery, University of Ghent, Ghent, Belgium.
FAU - Lapauw, Bruno
AU  - Lapauw B
AD  - Department of Endocrinology, University of Ghent, Ghent, Belgium.
FAU - Lakhtakia, Sundeep
AU  - Lakhtakia S
AD  - Asian Institute of Gastroenterology, Hyderabad, India.
FAU - Sundaram, Sridhar
AU  - Sundaram S
AD  - Department of Digestive Diseases and Clinical Nutrition, Tata Memorial Hospital, 
      Mumbai, India.
FAU - Samanta, Jayanta
AU  - Samanta J
AD  - Departments of Gastroenterology, Postgraduate Institute of Medical Education and 
      Research, Chandigarh, India.
FAU - Rastogi, Ashu
AU  - Rastogi A
AD  - Department of Endocrinology, Post Graduate Institute of Medical Education and 
      Research, Chandigarh, India.
FAU - Landoni, Luca
AU  - Landoni L
AD  - General and Pancreatic Surgery Department, Pancreas Institute, University of 
      Verona Hospital Trust, Verona, Italy.
LA  - eng
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20230703
PL  - Netherlands
TA  - Dig Liver Dis
JT  - Digestive and liver disease : official journal of the Italian Society of 
      Gastroenterology and the Italian Association for the Study of the Liver
JID - 100958385
SB  - IM
MH  - Humans
MH  - *Insulinoma/diagnostic imaging/surgery
MH  - *Pancreatic Neoplasms/surgery/pathology
MH  - Quality of Life
MH  - *Radiofrequency Ablation/methods
MH  - Endosonography/methods
MH  - Randomized Controlled Trials as Topic
MH  - Multicenter Studies as Topic
OTO - NOTNLM
OT  - Acute pancreatitis
OT  - Endoscopic ultrasound
OT  - Hypoglicemia
OT  - Insulin
OT  - Neuroendocrine tumors
OT  - Pancreatic fistula
COIS- Conflict of interest None declared.
EDAT- 2023/07/06 01:08
MHDA- 2023/08/28 06:43
CRDT- 2023/07/05 21:59
PHST- 2023/04/25 00:00 [received]
PHST- 2023/06/19 00:00 [revised]
PHST- 2023/06/21 00:00 [accepted]
PHST- 2023/08/28 06:43 [medline]
PHST- 2023/07/06 01:08 [pubmed]
PHST- 2023/07/05 21:59 [entrez]
AID - S1590-8658(23)00719-3 [pii]
AID - 10.1016/j.dld.2023.06.021 [doi]
PST - ppublish
SO  - Dig Liver Dis. 2023 Sep;55(9):1187-1193. doi: 10.1016/j.dld.2023.06.021. Epub 
      2023 Jul 3.