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Completed

NCT Number: NCT03791346

Pancreatectomy for NET: External Evaluation of WHO 2017 Grading System

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. Overall survival at 5 years

    Time frame: 5 years

    Overall survival (OS) (time from diagnosis until death, regardless of cause)

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Department of digestive surgery, Carémeau Hospital, 30900, Nîmes, France
  • Department of oncology, Carémeau Hospital, 30900, Nîmes, France
  • Digestive & Oncologic Surgery - Institut du Cancer de Montpellier (ICM), Montpellier, France
  • Oncology - Institut du Cancer de Montpellier (ICM), Montpellier, France

Registry information

Official study title

Outcome After Pancreatectomy for Neuroendocrine Tumor and Evaluation of the WHO 2017 Grading System: a Retrospective Multicentric Analysis of 138 Consecutive Patients.

Acronym: PanTEN

Important dates

Study start
1997
Primary completion
2017
Study completion
2019
First posted
Jan 2, 2019
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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