Management of Asymptomatic Sporadic Nonfunctioning Pancreatic Neuroendocrine Neoplasms (ASPEN) ≤2 cm: Study Protocol for a Prospective Observational Study

被引：34

作者：

Partelli, Stefano ^{[1
]}

Ramage, John K. ^{[2
]}

Massironi, Sara ^{[3
]}

Zerbi, Alessandro ^{[4
]}

Kim, Hong Beom ^{[5
]}

Niccoli, Patricia ^{[6
]}

Panzuto, Francesco ^{[7
]}

Landoni, Luca ^{[8
,9
]}

Tomazic, Ales ^{[10
]}

Ibrahim, Toni ^{[11
]}

Kaltsas, Gregory ^{[12
]}

Bertani, Emilio ^{[13
]}

Sauvanet, Alain ^{[14
]}

Segelov, Eva ^{[15
]}

Caplin, Martyn ^{[16
]}

Coppa, Jorgelina ^{[17
,18
]}

Armstrong, Thomas ^{[19
]}

Weickert, Martin O. ^{[20
]}

Butturini, Giovanni ^{[21
]}

Staettner, Stefan ^{[22
]}

Boesch, Florian ^{[23
]}

Cives, Mauro ^{[24
]}

Moulton, Carol Anne ^{[25
,26
]}

He, Jin ^{[27
]}

Selberherr, Andreas ^{[28
]}

Twito, Orit ^{[29
]}

Castaldi, Antonio ^{[30
]}

De Angelis, Claudio Giovanni ^{[31
]}

Gaujoux, Sebastien ^{[32
]}

Almeamar, Hussein ^{[33
]}

Frilling, Andrea ^{[34
]}

Vigia, Emanuel ^{[35
]}

Wilson, Colin ^{[36
]}

Muffatti, Francesca ^{[1
]}

Srirajaskanthan, Raj ^{[2
]}

Invernizzi, Pietro ^{[3
]}

Lania, Andrea ^{[4
]}

Kwon, Wooil ^{[5
]}

Ewald, Jacques ^{[6
]}

Rinzivillo, Maria ^{[7
]}

Nessi, Chiara ^{[8
,9
]}

Smid, Lojze M. ^{[10
]}

Gardini, Andrea ^{[37
]}

Tsoli, Marina ^{[12
]}

Picardi, Edgardo E. ^{[13
]}

Hentic, Olivia ^{[14
]}

Croagh, Daniel ^{[15
]}

Toumpanakis, Christos ^{[16
]}

Citterio, Davide ^{[17
,18
]}

Ramsey, Emma ^{[19
]}

机构：

[1] IRCCS San Raffaele Sci Inst, Pancreas Translat & Clin Res Ctr, Pancreat Surg Unit, Milan, Italy

[2] Kings Coll Hosp London, Kings Hlth Partners NET Ctr, London, England

[3] Univ Milano Bicocca, Ctr Autoimmune Liver Dis, Div Gastroenterol, Dept Med & Surg, Monza, Italy

[4] Humanitas Clin & Res Ctr, IRCCS, Rozzano, Italy

[5] Seoul Natl Univ, Seoul Natl Univ Hosp, Dept Surg, Coll Med, Seoul, South Korea

[6] Calmettes Inst, Dept Med Oncol, Marseille, France

[7] Sant Andrea Univ Hosp, ENETS Ctr Excellence, Digest Dis Unit, Rome, Italy

[8] Univ Verona, Dept Surg, Pancreas Inst, Verona ENETS Ctr Excellence, Verona, Italy

[9] Hosp Trust Verona, Verona, Italy

[10] Univ Ljubljana, Univ Med Ctr Ljubljana, Fac Med, Dept Abdominal Surg & Gastroenterol & Hepatol, Ljubljana, Slovenia

[11] IRST IRCCS, Osteoncol & Rare Tumors Ctr, Meldola, Italy

[12] Kapodistrian Univ Athens, Laiko Univ Hosp, Dept Propaedeut & Internal Med 1, Athens, Greece

[13] European Inst Oncol, Div Gastrointestinal Surg, Milan, Italy

[14] Univ Paris 07, Beaujon Hosp, AP HP, Dept HPB Surg & Liver Transplantat & Pancreatol, 100 Blvd Gen Leclerc, Clichy, France

[15] Monash Univ, Sch Clin Sci, Dept Oncol & Surg, Monash Hlth, Clayton, Vic, Australia

[16] Royal Free Hosp, Centre Gastroenterol, ENETS Centre Excellence, Neuroendocrine Tumour Unit, London, England

[17] Fdn IRCCS Ist Nazl Tumori, Gastrointestinal & Hepatopancreat Surg & Liver Tr, INT, Natl Canc Inst, Milan, Italy

[18] Univ Milan, Milan, Italy

[19] Univ Hosp Southampton, Wessex NET Grp, Dept Hepatobiliary Surg, ENETS Ctr Excellence, Southampton, Hants, England

[20] Univ Hosp Coventry & Warwickshire NHS Trust, ARDEN NET Ctr, European Neuroendocrine Tumour Soc, Ctr Excellence CoE, Coventry, W Midlands, England

[21] Pederzoli Hosp, Dept Surg, Peschiera Del Garda, Italy

[22] Salzkammergutklinikum Vocklabruck, Dept Gen Visceral & Vasc Surg, Vocklabruck, Austria

[23] Ludwig Maximilians Univ Munchen, Dept Gen Visceral & Transplantat Surg, Univ Hosp, Munich, Germany

[24] Univ Bari Aldo Moro, Dept Biomed Sci & Clin Oncol DIMO, Sect Med Oncol, Bari, Italy

[25] Univ Toronto, Div Gen Surg, Toronto, ON, Canada

[26] Univ Toronto, Univ Hlth Network, Princess Margaret Canc Ctr, Dept Surg, Toronto, ON, Canada

[27] Johns Hopkins Med Inst, Sol Goldman Pancreat Canc Res Ctr, Dept Surg, Baltimore, MA USA

[28] Med Univ, Dept Surg, Div Gen Surg, Sect Endocrine Surg, Vienna, Austria

[29] Tel Aviv Univ, Endocrine Inst, Meir Med Ctr, Sackler Fac Med, Tel Aviv, Israel

[30] Univ Naples Federico II, Dept Clin Med & Surg, Naples, Italy

[31] City Hlth & Sci Hosp, Dept Med Sci, Gastroenterol Unit, Turin, Italy

[32] Paris Descartes Univ, Cochin Hosp, Dept Digest Hepatobiliary & Endocrine Surg, Cochin Hosp, Paris, France

[33] St Vincents Univ Hosp, Natl NET Ctr, ENETS Ctr Excellence, Dublin, Ireland

[34] Imperial Coll London, Dept Surg & Canc, London, England

[35] Nova Univ Lisbon, Hosp Curry Cabral, Ctr Hepatobiliopancreat, Lisbon, Portugal

[36] Newcastle Tyne Teaching Hosp Fdn Trust, HPB Surg Unit, Newcastle Upon Tyne, Tyne & Wear, England

[37] Morgagni Pierantoni Hosp, Gen & Onclg Surg Unit, Forli, Italy

[38] Med Univ Innsbruck, Dept Visceral Transplantat & Thorac Surg, Innsbruck, Austria

[39] Univ Milan, Dept Pathophysiol & Transplantat, Milan, Italy

来源：

FRONTIERS IN MEDICINE | 2020年 / 7卷

关键词：

small nonfunctioning pancreatic neuroendocrine neoplasm; NF-PanNEN_2 cm; management; surgery; surveillance; follow-up; ASPEN study; ENETS CONSENSUS GUIDELINES; SURGICAL-MANAGEMENT; TUMORS; SURVEILLANCE; RESECTION; BEHAVIOR; OUTCOMES;

D O I：

10.3389/fmed.2020.598438

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Introduction: The optimal treatment for small, asymptomatic, nonfunctioning pancreatic neuroendocrine neoplasms (NF-PanNEN) is still controversial. European Neuroendocrine Tumor Society (ENETS) guidelines recommend a watchful strategy for asymptomatic NF-PanNEN <2 cm of diameter. Several retrospective series demonstrated that a non-operative management is safe and feasible, but no prospective studies are available. Aim of the ASPEN study is to evaluate the optimal management of asymptomatic NF-PanNEN <= 2 cm comparing active surveillance and surgery. Methods: ASPEN is a prospective international observational multicentric cohort study supported by ENETS. The study is registered in with the identification code NCT03084770. Based on the incidence of NF-PanNEN the number of expected patients to be enrolled in the ASPEN study is 1,000 during the study period (2017-2022). Primary endpoint is disease/progression-free survival, defined as the time from study enrolment to the first evidence of progression (active surveillance group) or recurrence of disease (surgery group) or death from disease. Inclusion criteria are: age >18 years, the presence of asymptomatic sporadic NF-PanNEN <= 2 cm proven by a positive fine-needle aspiration (FNA) or by the presence of a measurable nodule on high-quality imaging techniques that is positive at (68)Gallium DOTATOC-PET scan. Conclusion: The ASPEN study is designed to investigate if an active surveillance of asymptomatic NF-PanNEN <= 2 cm is safe as compared to surgical approach.

引用

页数：8

共 46 条

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