Pancreatectomy for NET: External Evaluation of WHO 2017 Grading System

NCT03791346 | Completed

• 1 other identifier: RECHMPL18_0492
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Surgery

Keywords

neuroendocrine tumor; Survival; WHO 2017 grading system; pancreatectomy; Laparoscopy; Postoperative outcomes

Outcome Measures

Primary Outcomes (1)

• Disease-free survival at 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)

  5 years

Secondary Outcomes (1)

• Overall survival at 5 years

  5 years

Eligibility Criteria

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

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

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

Study Officials

• REGIS SOUCHE

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2018
• First Posted: January 2, 2019
• Study Start: January 1, 1997
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2019
• Last Updated: April 18, 2019

Record last verified: 2018-12

Locations

FR (1)