Pancreatectomy for NET: External Evaluation of WHO 2017 Grading System

Pancreatic Surgery Clinical Trial

— PanTEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03791346
• Other study ID #: RECHMPL18_0492
• Status: Completed
• Start date: January 1, 1997
• Est. completion date: February 1, 2019

Study information

• Verified date: December 2018
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: February 1, 2019
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuroendocrine Tumors
• Pancreatic Surgery

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Montpellier	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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival at 5 years	Overall survival (OS) (time from diagnosis until death, regardless of cause)	5 years