Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 35 of 1442 for:    survival | Neuroendocrine Tumors

Portal Vein Resection in Pancreatic Neuroendocrine Tumours (PVNET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04336839
Recruitment Status : Not yet recruiting
First Posted : April 7, 2020
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Pancreas Neoplasm Neuroendocrine Tumors Procedure: Portal vein resection / reconstruction

Layout table for study information
Study Type : Observational
Estimated 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
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : August 31, 2020



Intervention Details:
  • Procedure: Portal vein resection / reconstruction
    Portal vein resection and reconstruction, with or without concommitant arterial resection


Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: 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 [ Time Frame: total of 2 years retrospective follow up ]
    Postoperative morbidity and mortality

  2. Histology predictive value [ Time Frame: total of 2 years retrospective follow up ]
    Predictive value of histologically proven invasion of the portal vein adventitia



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients operated for pancreatic neuroendocrine tumours within a single tertiary referal centre
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04336839


Contacts
Layout table for location contacts
Contact: Panagis M Lykoudis, MD, MSc +44(0)7413738787 p.lykoudis@ucl.ac.uk
Contact: Giuseppe K Fusai, MD MS 0044(0)2077940500 ext 33603 g.fusai@ucl.ac.uk

Sponsors and Collaborators
Royal Free Hospital NHS Foundation Trust
Investigators
Layout table for investigator information
Principal Investigator: Giuseppe K Fusai, MD MS Royal Free London NHS Foundation Trust & University College London
Publications of Results:
Layout table for additonal information
Responsible Party: Royal Free Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04336839    
Other Study ID Numbers: 11536
First Posted: April 7, 2020    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared with other researchers

Layout table for additional information
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:
Layout table for MeSH terms
Neoplasms
Neuroendocrine Tumors
Pancreatic Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases