Portal Vein Resection in Pancreatic Neuroendocrine Tumours

Neuroendocrine Tumors Clinical Trial

— PVNET  

Official title:

Vascular Resection During Pancreaticoduodenectomy for Pancreatic Neuroendocrine Neoplasms (PanNENs): a Comparative Single Centre Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04336839
• Other study ID #: 11536
• Status: Not yet recruiting
• Start date: May 1, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: April 2020
• Source: Royal Free Hospital NHS Foundation Trust
• Contact: Panagis M Lykoudis, MD, MSc
• Phone: +44(0)7413738787
• Email: p.lykoudis[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 31, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Neuroendocrine Tumors
• Pancreas Neoplasm
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Royal Free Hospital NHS Foundation Trust

References & Publications (5)

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 pa — View 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 S — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival	Time from surgery to disease progression, or death or completion of follow up	total of 2 years retrospective follow up
Secondary	Morbidity and mortality rate	Postoperative morbidity and mortality	total of 2 years retrospective follow up
Secondary	Histology predictive value	Predictive value of histologically proven invasion of the portal vein adventitia	total of 2 years retrospective follow up