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2020-05-01
2020-06-15
2020-08-31
40
NCT04336839
Royal Free Hospital NHS Foundation Trust
Royal Free Hospital NHS Foundation Trust
OBSERVATIONAL
Portal Vein Resection in Pancreatic Neuroendocrine Tumours
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
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-04-03 | N/A | 2020-04-03 |
2020-04-03 | N/A | 2020-04-07 |
2020-04-07 | N/A | 2020-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Progression-Free Survival | Time from surgery to disease progression, or death or completion of follow up | total of 2 years retrospective follow up |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Morbidity and mortality rate | Postoperative morbidity and mortality | total of 2 years retrospective follow up |
| Histology predictive value | Predictive value of histologically proven invasion of the portal vein adventitia | total of 2 years retrospective follow up |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Panagis M Lykoudis, MD, MSc Phone Number: +44(0)7413738787 Email: p.lykoudis@ucl.ac.uk |
Study Contact Backup Name: Giuseppe K Fusai, MD MS Phone Number: 0044(0)2077940500 Email: g.fusai@ucl.ac.uk |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
