Diagnostic Accuracy of Preoperative Diagnostic Procedure in the Assessment of Lymph Node Metastases by NF-PanNENs

NCT03918759 | Completed

• 1 other identifier: DETECTYON study
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Pancreatic Neuroendocrine Neoplasms (PanNEN) are a heterogeneous group of neoplasms that arise from the endocrine cells of the pancreatic gland. Non-functioning (NF-PanNEN) represents the most common forms and do not produce syndromes due to hormonal hypersecretion. Several prognostic factors have been demonstrated for NF-PanNEN. The presence of nodal metastasis and lymph node ratio are widely considered predictors of disease-free survival and even the number of positive nodes has been found to be associated with recurrence. In addition to traditional imaging exams, diagnostic work-up should include a Positron Emission Tomography/CT with 68Ga labeled somatostatin analogues, which have shown a high sensitivity and specificity while 18F-FDG PET can be associated for evaluating the possible presence of a high-grade component. Moreover, pancreatic endoscopic ultrasound (EUS) is usually part of the preoperative staging both for imaging details and cytological sampling. Therefore an accurate identification of nodal metastases preoperatively may have important implications for the extent of surgical resection and lymphadenectomy and even for a prognostic outcome. In this study the investigators will evaluate prospectively the accuracy of these diagnostic exams in detecting the lymph node status. Patients with sporadic NF-PanNEN who are candidates for surgical resection will undergo CE-CT scan, 68Ga DOTATOC (and eventually 18F-FDG) PET/MRI and EUS with FNA/B. Reference standard for defining the presence of nodal metastases is represented by pathological examination on the specimen.

Conditions

Non Functioning Pancreatic Endocrine Tumor

Keywords

Lymph node metastases; Diagnostic accuracy

Outcome Measures

Primary Outcomes (1)

• Accuracy of preoperative staging in detecting nodal metastases by evaluating and comparing sensitivity and specificity of the diagnostic techniques

  The primary endpoint of the study is to assess the accuracy of preoperative diagnostic procedures in terms of sensitivity and specificity in detecting nodal metastases in sporadic NF-PanNEN

  2 years

Secondary Outcomes (2)

• Evaluate the prognostic role of the nodal involvement

  5 years

• Evaluate the correlation between preoperative radiological and/or clinical data and nodal involvement

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

150 patients with a suspect of a sporadic NF-PanNEN will be considered for the study at the time of the first visit. All consecutive patients who will meet inclusion criteria, after informed consent, will be included. The enrollment will be completed only after the cytological/histological confirmation NF-PanNEN.

You may qualify if:

• Age \> 18 years
• Individuals with a diagnosis of NF-PanNEN undergoing standard pancreatic resection (pancreatoduodenectomy, left pancreatectomy, total pancreatectomy)
• Cytologically/histologically proven diagnosis of NF-PanNEN.
• Informed consent

You may not qualify if:

• Age \< 18 years
• Absence of cytological/histological confirmation
• Presence of functioning PanNEN
• Presence of genetic syndrome (MEN1, VHL, NF)
• Patients undergone previously to an EUS in another institution with a FNA/B positive for NET

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele Hospital

Milan, 20132, Italy

Location

Related Publications (10)

• Boninsegna L, Panzuto F, Partelli S, Capelli P, Delle Fave G, Bettini R, Pederzoli P, Scarpa A, Falconi M. Malignant pancreatic neuroendocrine tumour: lymph node ratio and Ki67 are predictors of recurrence after curative resections. Eur J Cancer. 2012 Jul;48(11):1608-15. doi: 10.1016/j.ejca.2011.10.030. Epub 2011 Nov 28.

  PMID: 22129889 BACKGROUND

• Hashim YM, Trinkaus KM, Linehan DC, Strasberg SS, Fields RC, Cao D, Hawkins WG. Regional lymphadenectomy is indicated in the surgical treatment of pancreatic neuroendocrine tumors (PNETs). Ann Surg. 2014 Feb;259(2):197-203. doi: 10.1097/SLA.0000000000000348.

  PMID: 24253141 BACKGROUND

• Partelli S, Javed AA, Andreasi V, He J, Muffatti F, Weiss MJ, Sessa F, La Rosa S, Doglioni C, Zamboni G, Wolfgang CL, Falconi M. The number of positive nodes accurately predicts recurrence after pancreaticoduodenectomy for nonfunctioning neuroendocrine neoplasms. Eur J Surg Oncol. 2018 Jun;44(6):778-783. doi: 10.1016/j.ejso.2018.03.005. Epub 2018 Mar 17.

  PMID: 29610023 BACKGROUND

• Deppen SA, Blume J, Bobbey AJ, Shah C, Graham MM, Lee P, Delbeke D, Walker RC. 68Ga-DOTATATE Compared with 111In-DTPA-Octreotide and Conventional Imaging for Pulmonary and Gastroenteropancreatic Neuroendocrine Tumors: A Systematic Review and Meta-Analysis. J Nucl Med. 2016 Jun;57(6):872-8. doi: 10.2967/jnumed.115.165803. Epub 2016 Jan 14.

  PMID: 26769864 BACKGROUND

• Miyazaki M, Ohtsuka M, Miyakawa S, Nagino M, Yamamoto M, Kokudo N, Sano K, Endo I, Unno M, Chijiiwa K, Horiguchi A, Kinoshita H, Oka M, Kubota K, Sugiyama M, Uemoto S, Shimada M, Suzuki Y, Inui K, Tazuma S, Furuse J, Yanagisawa A, Nakanuma Y, Kijima H, Takada T. Classification of biliary tract cancers established by the Japanese Society of Hepato-Biliary-Pancreatic Surgery: 3(rd) English edition. J Hepatobiliary Pancreat Sci. 2015 Mar;22(3):181-96. doi: 10.1002/jhbp.211. Epub 2015 Feb 17.

  PMID: 25691463 BACKGROUND

• Toste PA, Kadera BE, Tatishchev SF, Dawson DW, Clerkin BM, Muthusamy R, Watson R, Tomlinson JS, Hines OJ, Reber HA, Donahue TR. Nonfunctional pancreatic neuroendocrine tumors <2 cm on preoperative imaging are associated with a low incidence of nodal metastasis and an excellent overall survival. J Gastrointest Surg. 2013 Dec;17(12):2105-13. doi: 10.1007/s11605-013-2360-9. Epub 2013 Oct 8.

  PMID: 24101447 BACKGROUND

• Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

  PMID: 19097774 BACKGROUND

• Dasari A, Shen C, Halperin D, Zhao B, Zhou S, Xu Y, Shih T, Yao JC. Trends in the Incidence, Prevalence, and Survival Outcomes in Patients With Neuroendocrine Tumors in the United States. JAMA Oncol. 2017 Oct 1;3(10):1335-1342. doi: 10.1001/jamaoncol.2017.0589.

  PMID: 28448665 RESULT

• Gao Y, Gao H, Wang G, Yin L, Xu W, Peng Y, Wu J, Jiang K, Miao Y. A meta-analysis of Prognostic factor of Pancreatic neuroendocrine neoplasms. Sci Rep. 2018 May 8;8(1):7271. doi: 10.1038/s41598-018-24072-0.

  PMID: 29739948 RESULT

• Partelli S, Muffatti F, Andreasi V, Giannone F, Rossi G, Palumbo D, Mapelli P, Schiavo Lena M, Arcidiacono PG, De Cobelli F, Picchio M, Doglioni C, Falconi M. A Single-center Prospective Observational Study Investigating the Accuracy of Preoperative Diagnostic Procedures in the Assessment of Lymph Node Metastases in Nonfunctioning Pancreatic Neuroendocrine Tumors. Ann Surg. 2022 Nov 1;276(5):921-928. doi: 10.1097/SLA.0000000000005615. Epub 2022 Aug 5.

  PMID: 35930017 DERIVED

MeSH Terms

Conditions

Non functioning pancreatic endocrine tumor; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefano Partelli, MD, PhD

  IRCCS San Raffaele

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: April 18, 2019
• Study Start: November 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)