Portal Vein Resection in Pancreatic Neuroendocrine Tumours

NCT04336839 | Unknown

• 1 other identifier: 11536
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pancreas Neoplasm; Neuroendocrine Tumors

Keywords

portal vein resection; pancreatic surgery

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  Time from surgery to disease progression, or death or completion of follow up

  total of 2 years retrospective follow up

Secondary Outcomes (2)

• Morbidity and mortality rate

  total of 2 years retrospective follow up

• Histology predictive value

  total of 2 years retrospective follow up

Interventions

Portal vein resection / reconstruction PROCEDURE

Portal vein resection and reconstruction, with or without concommitant arterial resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients operated for pancreatic neuroendocrine tumours within a single tertiary referal centre

You may qualify if:

• 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.

You may not qualify if:

• Multiple Neuroendocrine Neoplasia (MEN) syndrome or other genetic background
• Age \<18 years old
• Total pancreatectomy or different operation rather than PD
• R2 Resections

Sponsors & Collaborators

• Royal Free Hospital NHS Foundation Trust: lead

Related Publications (5)

• 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.

  PMID: 15532841 RESULT

• 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.

  PMID: 15849513 RESULT

• 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.

  PMID: 11174708 RESULT

• 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.

  PMID: 24484730 RESULT

• 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.

  PMID: 26346183 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms; Neuroendocrine Tumors

Interventions

Plastic Surgery Procedures

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Giuseppe K Fusai, MD MS

  Royal Free London NHS Foundation Trust & University College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Panagis M Lykoudis, MD, MSc

CONTACT

+44(0)7413738787; p.lykoudis@ucl.ac.uk

Giuseppe K Fusai, MD MS

CONTACT

0044(0)2077940500; g.fusai@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 7, 2020
• Study Start: May 1, 2020
• Primary Completion: June 15, 2020
• Study Completion: August 31, 2020
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share