Pancreas NeoplasmPVNETNCT04336839
Portal Vein Resection in Pancreatic Neuroendocrine Tumours
An observational study of Pancreas Neoplasm and Neuroendocrine Tumors, run by Royal Free Hospital NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreas Neoplasm, Neuroendocrine Tumors
- What is being tested?
- Portal vein resection / reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to 31 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients operated for pancreatic neuroendocrine tumours within a single tertiary referal centre
Who may be able to join
- 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.
Who cannot join
- Multiple Neuroendocrine Neoplasia (MEN) syndrome or other genetic background
- Age <18 years old
- Total pancreatectomy or different operation rather than PD
- R2 Resections
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Vascular Resection During Pancreaticoduodenectomy for Pancreatic Neuroendocrine Neoplasms (PanNENs): a Comparative Single Centre Study
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
- Conditions
- Pancreas Neoplasm, Neuroendocrine Tumors
- Being tested
- Portal vein resection / reconstruction
- Keywords
- portal vein resection, pancreatic surgery
- Medical subject headings
- Pancreatic Neoplasms, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portal vein resection / reconstructionProcedure or surgery
Portal vein resection and reconstruction, with or without concommitant arterial resection
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Time from surgery to disease progression, or death or completion of follow up
Measured: total of 2 years retrospective follow up
Secondary outcomes (2)
Morbidity and mortality rate
Postoperative morbidity and mortality
Measured: total of 2 years retrospective follow up
Histology predictive value
Predictive value of histologically proven invasion of the portal vein adventitia
Measured: total of 2 years retrospective follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start1 May 2020 (estimated)
- Primary completion15 Jun 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pancreas NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Free Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe K Fusai, MD MS, Principal investigator, Royal Free London NHS Foundation Trust & University College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336839
- Sponsor's protocol ID
- 11536
- Acronym
- PVNET
- Status last verified
- Apr 2020
- First submitted
- 3 Apr 2020
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other researchers
Publications
Sakamoto E, Hasegawa H, Ogiso S, Igami T, Mori T, Mizuno T, Hattori K, Sugimoto M, Fukami Y. Curative resection for a pancreatic endocrine carcinoma involving the portal vein. Hepatogastroenterology. 2004 Nov-Dec;51(60):1849-51.
PubMed 15532841Touzios JG, Kiely JM, Pitt SC, Rilling WS, Quebbeman EJ, Wilson SD, Pitt HA. Neuroendocrine hepatic metastases: does aggressive management improve survival? Ann Surg. 2005 May;241(5):776-83; discussion 783-5. doi: 10.1097/01.sla.0000161981.58631.ab.
PubMed 15849513van Geenen RC, ten Kate FJ, de Wit LT, van Gulik TM, Obertop H, Gouma DJ. Segmental resection and wedge excision of the portal or superior mesenteric vein during pancreatoduodenectomy. Surgery. 2001 Feb;129(2):158-63. doi: 10.1067/msy.2001.110221.
PubMed 11174708Ravikumar R, Sabin C, Abu Hilal M, Bramhall S, White S, Wigmore S, Imber CJ, Fusai G; UK Vascular Resection in Pancreatic Cancer Study Group. Portal vein resection in borderline resectable pancreatic cancer: a United Kingdom multicenter study. J Am Coll Surg. 2014 Mar;218(3):401-11. doi: 10.1016/j.jamcollsurg.2013.11.017. Epub 2013 Nov 27.
PubMed 24484730Elberm H, Ravikumar R, Sabin C, Abu Hilal M, Al-Hilli A, Aroori S, Bond-Smith G, Bramhall S, Coldham C, Hammond J, Hutchins R, Imber C, Preziosi G, Saleh A, Silva M, Simpson J, Spoletini G, Stell D, Terrace J, White S, Wigmore S, Fusai G. Outcome after pancreaticoduodenectomy for T3 adenocarcinoma: A multivariable analysis from the UK Vascular Resection for Pancreatic Cancer Study Group. Eur J Surg Oncol. 2015 Nov;41(11):1500-7. doi: 10.1016/j.ejso.2015.08.158. Epub 2015 Aug 28.
PubMed 26346183
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Resection During Pancreaticoduodenectomy for Pancreatic Neuroendocrine Neoplasms (PanNENs): a Comparative Single Centre Study
- ClinicalTrials.gov ID
- NCT04336839
- Acronym / sponsor ID
- PVNET / 11536
- Conditions
- Pancreas Neoplasm, Neuroendocrine Tumors
- Keywords
- portal vein resection, pancreatic surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Royal Free Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 15 Jun 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated for pancreatic neuroendocrine tumours within a single tertiary referal centre
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- Multiple Neuroendocrine Neoplasia (MEN) syndrome or other genetic background
- Age <18 years old
- Total pancreatectomy or different operation rather than PD
- R2 Resections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portal vein resection / reconstructionPortal vein resection and reconstruction, with or without concommitant arterial resection | Procedure or surgery | – |
Primary outcome
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
2 secondary outcomes
Morbidity and mortality rate
Time frame: total of 2 years retrospective follow up
Histology predictive value
Time frame: total of 2 years retrospective follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Results publication: PubMed 15532841Sakamoto E, Hasegawa H, Ogiso S, Igami T, Mori T, Mizuno T, Hattori K, Sugimoto M, Fukami Y. Curative resection for a pancreatic endocrine carcinoma involving the portal vein. Hepatogastroenterology. 2004 Nov-Dec;51(60):1849-51.
- Results publication: PubMed 15849513Touzios JG, Kiely JM, Pitt SC, Rilling WS, Quebbeman EJ, Wilson SD, Pitt HA. Neuroendocrine hepatic metastases: does aggressive management improve survival? Ann Surg. 2005 May;241(5):776-83; discussion 783-5. doi: 10.1097/01.sla.0000161981.58631.ab.
- Results publication: PubMed 11174708van Geenen RC, ten Kate FJ, de Wit LT, van Gulik TM, Obertop H, Gouma DJ. Segmental resection and wedge excision of the portal or superior mesenteric vein during pancreatoduodenectomy. Surgery. 2001 Feb;129(2):158-63. doi: 10.1067/msy.2001.110221.
- Results publication: PubMed 24484730Ravikumar R, Sabin C, Abu Hilal M, Bramhall S, White S, Wigmore S, Imber CJ, Fusai G; UK Vascular Resection in Pancreatic Cancer Study Group. Portal vein resection in borderline resectable pancreatic cancer: a United Kingdom multicenter study. J Am Coll Surg. 2014 Mar;218(3):401-11. doi: 10.1016/j.jamcollsurg.2013.11.017. Epub 2013 Nov 27.
- Results publication: PubMed 26346183Elberm H, Ravikumar R, Sabin C, Abu Hilal M, Al-Hilli A, Aroori S, Bond-Smith G, Bramhall S, Coldham C, Hammond J, Hutchins R, Imber C, Preziosi G, Saleh A, Silva M, Simpson J, Spoletini G, Stell D, Terrace J, White S, Wigmore S, Fusai G. Outcome after pancreaticoduodenectomy for T3 adenocarcinoma: A multivariable analysis from the UK Vascular Resection for Pancreatic Cancer Study Group. Eur J Surg Oncol. 2015 Nov;41(11):1500-7. doi: 10.1016/j.ejso.2015.08.158. Epub 2015 Aug 28.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe K Fusai, MD MS principal investigator
Royal Free London NHS Foundation Trust & University College London
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Neoplasm and Neuroendocrine Tumors, run by Royal Free Hospital NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Panagis M Lykoudis, MD, MSc (+44(0)7413738787, p.lykoudis@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (time frame: total of 2 years retrospective follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04336839, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.