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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ville Sallinen, MD PhD +358-9-4711
ville.sallinen@helsinki.fi


Study Location:

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Be Part of Research - Trial Details - Distal Pancreatectomy Pancreatic Fistula Risk Prediction Model Validation Study

Distal Pancreatectomy Pancreatic Fistula Risk Prediction Model Validation Study

Recruiting

Open to: ALL

Age: 18.0 - 99.0

Medical Conditions

Pancreatic Fistula
Fistula


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Distal pancreas resection is a relatively rare procedure with a known risk of postoperative pancreatic fistula. Until quite recently, no valid risk prediction models for this have been available. In 2022 two different risk scores DISPAIR and D-FRS were published. The aim of this study is to compare, validate and possibly improve those scores in a international retrospective multicenter cohort.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Apr 2023 Apr 2025

Publications

"Callery MP, Pratt WB, Kent TS, Chaikof EL, Vollmer CM Jr. A prospectively validated clinical risk score accurately predicts pancreatic fistula after pancreatoduodenectomy. J Am Coll Surg. 2013 Jan;216(1):1-14. doi: 10.1016/j.jamcollsurg.2012.09.002. Epub 2012 Nov 2."; "23122535"; "Mungroop TH, van Rijssen LB, van Klaveren D, Smits FJ, van Woerden V, Linnemann RJ, de Pastena M, Klompmaker S, Marchegiani G, Ecker BL, van Dieren S, Bonsing B, Busch OR, van Dam RM, Erdmann J, van Eijck CH, Gerhards MF, van Goor H, van der Harst E, de Hingh IH, de Jong KP, Kazemier G, Luyer M, Shamali A, Barbaro S, Armstrong T, Takhar A, Hamady Z, Klaase J, Lips DJ, Molenaar IQ, Nieuwenhuijs VB, Rupert C, van Santvoort HC, Scheepers JJ, van der Schelling GP, Bassi C, Vollmer CM, Steyerberg EW, Abu Hilal M, Groot Koerkamp B, Besselink MG; Dutch Pancreatic Cancer Group. Alternative Fistula Risk Score for Pancreatoduodenectomy (a-FRS): Design and International External Validation. Ann Surg. 2019 May;269(5):937-943. doi: 10.1097/SLA.0000000000002620."; "29240007"; "Mungroop TH, Klompmaker S, Wellner UF, Steyerberg EW, Coratti A, D'Hondt M, de Pastena M, Dokmak S, Khatkov I, Saint-Marc O, Wittel U, Abu Hilal M, Fuks D, Poves I, Keck T, Boggi U, Besselink MG; European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS). Updated Alternative Fistula Risk Score (ua-FRS) to Include Minimally Invasive Pancreatoduodenectomy: Pan-European Validation. Ann Surg. 2021 Feb 1;273(2):334-340. doi: 10.1097/SLA.0000000000003234. Erratum In: Ann Surg. 2022 Aug 01;276(2):e140. doi: 10.1097/SLA.0000000000005457."; "30829699"; "Ecker BL, McMillan MT, Allegrini V, Bassi C, Beane JD, Beckman RM, Behrman SW, Dickson EJ, Callery MP, Christein JD, Drebin JA, Hollis RH, House MG, Jamieson NB, Javed AA, Kent TS, Kluger MD, Kowalsky SJ, Maggino L, Malleo G, Valero V 3rd, Velu LKP, Watkins AA, Wolfgang CL, Zureikat AH, Vollmer CM Jr. Risk Factors and Mitigation Strategies for Pancreatic Fistula After Distal Pancreatectomy: Analysis of 2026 Resections From the International, Multi-institutional Distal Pancreatectomy Study Group. Ann Surg. 2019 Jan;269(1):143-149. doi: 10.1097/SLA.0000000000002491."; "28857813"; "De Pastena M, van Bodegraven EA, Mungroop TH, Vissers FL, Jones LR, Marchegiani G, Balduzzi A, Klompmaker S, Paiella S, Tavakoli Rad S, Groot Koerkamp B, van Eijck C, Busch OR, de Hingh I, Luyer M, Barnhill C, Seykora T, Maxwell T T, de Rooij T, Tuveri M, Malleo G, Esposito A, Landoni L, Casetti L, Alseidi A, Salvia R, Steyerberg EW, Abu Hilal M, Vollmer CM, Besselink MG, Bassi C. Distal Pancreatectomy Fistula Risk Score (D-FRS): Development and International Validation. Ann Surg. 2023 May 1;277(5):e1099-e1105. doi: 10.1097/SLA.0000000000005497. Epub 2022 Jul 7."; "35797608"; "Steyerberg EW, Harrell FE Jr. Prediction models need appropriate internal, internal-external, and external validation. J Clin Epidemiol. 2016 Jan;69:245-7. doi: 10.1016/j.jclinepi.2015.04.005. Epub 2015 Apr 18. No abstract available."; "25981519"

OBSERVATIONAL



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • NHS Lothian
    Edinburgh

Ville Sallinen, MD PhD +358-9-4711
ville.sallinen@helsinki.fi



The study is sponsored by University of Edinburgh and is in collaboration with Helsinki University Central Hospital; NHS Lothian, Royal Infirmary of Edinburgh.




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Read full details for Trial ID: NCT05737875
Last updated 09 December 2024

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