Pancreatectomy for NET: External Evaluation of WHO 2017 Grading System (PanTEN)

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ClinicalTrials.gov Identifier: NCT03791346

Recruitment Status : Completed

First Posted : January 2, 2019

Last Update Posted : April 18, 2019

Sponsor:

Collaborators:

Department of digestive surgery, Carémeau Hospital, 30900, Nîmes, France

Department of oncology, Carémeau Hospital, 30900, Nîmes, France

Oncology - Institut du Cancer de Montpellier (ICM), Montpellier, France

Digestive & Oncologic Surgery - Institut du Cancer de Montpellier (ICM), Montpellier, France

Information provided by (Responsible Party):

University Hospital, Montpellier

Study Description

Brief Summary:

Aim: The aim of this study was to investigate the clinicopathological factors and to evaluate the prognostic accuracy of the new World Health Organization (WHO) 2017 grading system in pancreatic neuroendocrine tumor (PanNET) patients.

Methods: Data collected between 1997 and December 2017 were analyzed. Histological grading and staging was based on the WHO 2017 grading system. Outcome after surgery and predictors of overall survival (OS) and disease free survival (DFS) were evaluated.

Condition or disease
Pancreatic Surgery

Study Design

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Study Type :	Observational
Actual Enrollment :	138 participants
Observational Model:	Cohort
Time Perspective:	Retrospective
Official Title:	Outcome After Pancreatectomy for Neuroendocrine Tumor and Evaluation of the WHO 2017 Grading System: a Retrospective Multicentric Analysis of 138 Consecutive Patients.
Actual Study Start Date :	January 1, 1997
Actual Primary Completion Date :	December 1, 2017
Actual Study Completion Date :	February 1, 2019

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Neuroendocrine Tumor Neuroepithelioma

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

Disease-free survival at 5 years [ Time Frame: 5 years ]
Disease-free survival (percentage of patients without recurrence) at 5 years. Disease-free survival (DFS) (time from diagnosis to time of first radiological evidence of local, regional, or distant relapse, or death due to any cause)

Secondary Outcome Measures :

Overall survival at 5 years [ Time Frame: 5 years ]
Overall survival (OS) (time from diagnosis until death, regardless of cause)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Retrospective review of collected data including all consecutive patients requiring a pancreatic resection for PanNET at 3 tertiary referral centers for pancreatic surgery in France, between December 1997 and December 2017. The 3 centers were Digestive Surgery Units of Montpellier, Nimes and Institute of Cancer at the University of Montpellier-Nimes.

Criteria

Inclusion criteria:

- patients with histologically proven neuroendocrine tumor located in pancreas who underwent pancreatic resection (by open, laparoscopic or robotic approach) even in case of distant metastasis at time of surgery, with no previous or concurrent malignancy.

Exclusion criteria:

- Patients with tumors diagnosed as adenocarcinoma with scattered neuroendocrine cells or with focal neuroendocrine component were excluded of this study.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03791346

Locations

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France
Uhmontpellier
Montpellier, France, 34295

Sponsors and Collaborators

University Hospital, Montpellier

Department of digestive surgery, Carémeau Hospital, 30900, Nîmes, France

Department of oncology, Carémeau Hospital, 30900, Nîmes, France

Oncology - Institut du Cancer de Montpellier (ICM), Montpellier, France

Digestive & Oncologic Surgery - Institut du Cancer de Montpellier (ICM), Montpellier, France

Investigators

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Study Director:	REGIS SOUCHE	University Hospital, Montpellier

More Information

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Responsible Party:	University Hospital, Montpellier
ClinicalTrials.gov Identifier:	NCT03791346
Other Study ID Numbers:	RECHMPL18_0492
First Posted:	January 2, 2019 Key Record Dates
Last Update Posted:	April 18, 2019
Last Verified:	December 2018

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by University Hospital, Montpellier:


neuroendocrine tumor Survival WHO 2017 grading system	pancreatectomy Laparoscopy Postoperative outcomes

Additional relevant MeSH terms:

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Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal	Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue

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