Clinical trial NCT04336839: Portal Vein Resection in Pancreatic Neuroendocrine Tumours
Official title: Vascular Resection During Pancreaticoduodenectomy for Pancreatic Neuroendocrine Neoplasms (PanNENs): a Comparative Single Centre Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreas Neoplasm
Neuroendocrine Tumors
Keywords: portal vein resection
pancreatic surgery
Lead sponsor: Royal Free Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated for pancreatic neuroendocrine tumours within a single tertiary referal centre

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


Eligibility 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

Primary outcomes:
measure: Progression-Free Survival
timeFrame: total of 2 years retrospective follow up
Secondary outcomes:
measure: Morbidity and mortality rate
timeFrame: total of 2 years retrospective follow up
measure: Histology predictive value
timeFrame: total of 2 years retrospective follow up
Other outcomes:
Locations:
Study officials:
affiliation: Royal Free London NHS Foundation Trust & University College London
name: Giuseppe K Fusai, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Touzios 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.
citation: van 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.
citation: Ravikumar 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.
citation: Elberm 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.