Portal Vein Resection in Pancreatic Neuroendocrine Tumours

• Conditions: Pancreas Neoplasm; Neuroendocrine Tumors

• Registration Number: NCT04336839
• Lead Sponsor: Royal Free Hospital NHS Foundation Trust

Brief Summary

The limited evidence on the value of portal vein resection in patients with borderline resectable and/or locally advanced PanNENs is an incentive to carry out a retrospective multicentre study amongst centres with specific interest in the management of PanNENs and with experience on vascular reconstruction. Unlike previous studies on pancreatic cancer, it is more difficult to standardise the comparative parameters as the definition of borderline resectable disease has never been published for PanNENs. Similarly, different histological classifications make impossible to collect data exclusively on T3 tumours. Therefore, we aim to compare the short and long-term outcomes (including the impact of the histological depth of vascular invasion on survival) between patients undergoing standard PD and PD with portal vein resection for PanNENs, (regardless of T stage), by collecting and analysing retrospective data in this single centre study

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-04-03
• Last Update Submitted: 2020-04-03
• Study First Posted: 2020-04-07
• Last Update Posted: 2020-04-07
• Study Start: 2020-05-01
• Primary Completion: 2020-06-15
• Study Completion: 2020-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

All patients undergoing pancreaticoduodenectomy (Whipple's or Pylorus Preserving Pancreaticoduodenectomy) for sporadic PanNENs of the head of the pancreas of any stage (R0 or R1 resections) operated from 1st January 2007 up to 31st December 2016 inclusive.

Exclusion Criteria

• Multiple Neuroendocrine Neoplasia (MEN) syndrome or other genetic background
• Age <18 years old
• Total pancreatectomy or different operation rather than PD
• R2 Resections

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival	total of 2 years retrospective follow up	Time from surgery to disease progression, or death or completion of follow up

Secondary Outcome Measures

Name	Time	Method
Histology predictive value	total of 2 years retrospective follow up	Predictive value of histologically proven invasion of the portal vein adventitia
Morbidity and mortality rate	total of 2 years retrospective follow up	Postoperative morbidity and mortality