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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT03791346

Collaborator

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

138

Enrollment

Location

265

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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	Intervention/Treatment	Phase
Pancreatic Surgery

Study Design

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 :

Jan 1, 1997

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Feb 1, 2019

Outcome Measures

Primary Outcome Measures

Disease-free survival at 5 years [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 [5 years]
Overall survival (OS) (time from diagnosis until death, regardless of cause)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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