PVNET: Portal Vein Resection in Pancreatic Neuroendocrine Tumours

• Sponsor: Royal Free Hospital NHS Foundation Trust (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04336839
• Collaborator: (none)
• Enrollment: 40
• Anticipated Duration (Months): 4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pancreas Neoplasm; Neuroendocrine Tumors	Procedure: Portal vein resection / reconstruction

Study Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Vascular Resection During Pancreaticoduodenectomy for Pancreatic Neuroendocrine Neoplasms (PanNENs): a Comparative Single Centre Study
• Anticipated Study Start Date: May 1, 2020
• Anticipated Primary Completion Date: Jun 15, 2020
• Anticipated Study Completion Date: Aug 31, 2020

Outcome Measures

Primary Outcome Measures

1. 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

1. Morbidity and mortality rate [total of 2 years retrospective follow up]

   Postoperative morbidity and mortality

2. Histology predictive value [total of 2 years retrospective follow up]

   Predictive value of histologically proven invasion of the portal vein adventitia

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Royal Free Hospital NHS Foundation Trust

Investigators

• Principal Investigator: Giuseppe K Fusai, MD MS, Royal Free London NHS Foundation Trust & University College London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Royal Free Hospital NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT04336839
• Other Study ID Numbers: 11536
• First Posted: Apr 7, 2020
• Last Update Posted: Apr 7, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Royal Free Hospital NHS Foundation Trust: portal vein resection; pancreatic surgery
• Additional relevant MeSH terms: Neoplasms; Neuroendocrine Tumors; Pancreatic Neoplasms

Study Results

No Results Posted as of Apr 7, 2020