Benchmarking Outcomes in Pancreatic Surgery - WhippleBenchmarks.Org
NCT ID: NCT04053998
Last Updated: 2020-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1462 participants
OBSERVATIONAL
2019-08-09
2020-02-20
Brief Summary
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Detailed Description
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The aim is to conduct a retrospective multicenter cohort study to define benchmark values for best achievable outcomes following duodenopancreatectomy (DP) with portal vein resection (PVR).
Data collection and study design are based on to the well established standardized reporting for benchmarking (Sánchez-Velázquez et. al. Ann Surg, February 2019 ).
This multicenter cohort study will include all consecutive pancreaticoduodenectomies with portal vein resections from at least 20 high volume centers performing over 50 pancreatic operations per year or 150 cases within 3 years from at least 3 continents over a period of 10 years (2009-2019). Every center included in the study must have a prospective database from which data can be collected as well as previous publications critically reporting on their outcome.
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Pancreaticoduodenectomy with portal vein resection
Pancreatic surgery with vein resection to achieve disease clearance.
Eligibility Criteria
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Inclusion Criteria
* Resectable malignant or benign diseases (i.e. all indications)
* Open pancreaticoduodenectomy (all techniques allowed) with concurrent portal vein resection
Exclusion Criteria
* Pancreatic resections other than pancreaticoduodenectomy and portal vein resection
* Pancreaticoduodenectomy with arterial reconstruction
* Laparoscopic or robotic pancreaticoduodenectomy
18 Years
ALL
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Cancer Institute Hospital, Japan
OTHER
Hospital Curry Cabral, CHLC, Lisbon, Portugal
UNKNOWN
St. Joseph's Hospital of Atlanta
OTHER
Erasmus Medical Center
OTHER
Hospital Italiano de Buenos Aires
OTHER
Juntendo University
OTHER
Parc de Salut Mar
OTHER
Queen Elizabeth Hospital NHS Foundation Trust
OTHER
Rennes University Hospital, Rennes, France
UNKNOWN
San Raffaele University Hospital, Italy
OTHER
St. Vincent's University Hospital, Dublin, Ireland
UNKNOWN
Thomas Jefferson University
OTHER
University of Dublin, Trinity College
OTHER
University of Lyon
OTHER
Mainz University
OTHER
University of Pisa
OTHER
Azienda Ospedaliera Universitaria Integrata Verona
OTHER
University Hospital Southampton NHS Foundation Trust
OTHER
University Hospital, Zürich
OTHER
Amsterdam UMC, location VUmc
OTHER
University of Colorado, Denver
OTHER
Severance Hospital
OTHER
Royal Free Hospital NHS Foundation Trust
OTHER
Responsible Party
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Dimitri Raptis
Senior Clinical Fellow in HPB and Transplant Surgery
Principal Investigators
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Giuseppe K Fusai, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Free Hospital, London, UK
Dimitri A Raptis, MD, MSc, PhD
Role: PRINCIPAL_INVESTIGATOR
Royal Free Hospital, London, UK
Patricia Sánchez Velázquez, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Parc de Salut Mar, Barcelona, Spain
Nikolaos Machairas, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Free Hospital, London, UK
Locations
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Parc de Salut Mar
Barcelona, , Spain
Royal Free Hospital
London, , United Kingdom
Countries
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References
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Sanchez-Velazquez P, Muller X, Malleo G, Park JS, Hwang HK, Napoli N, Javed AA, Inoue Y, Beghdadi N, Kalisvaart M, Vigia E, Walsh CD, Lovasik B, Busquets J, Scandavini C, Robin F, Yoshitomi H, Mackay TM, Busch OR, Hartog H, Heinrich S, Gleisner A, Perinel J, Passeri M, Lluis N, Raptis DA, Tschuor C, Oberkofler CE, DeOliveira ML, Petrowsky H, Martinie J, Asbun H, Adham M, Schulick R, Lang H, Koerkamp BG, Besselink MG, Han HS, Miyazaki M, Ferrone CR, Fernandez-Del Castillo C, Lillemoe KD, Sulpice L, Boudjema K, Del Chiaro M, Fabregat J, Kooby DA, Allen P, Lavu H, Yeo CJ, Barroso E, Roberts K, Muiesan P, Sauvanet A, Saiura A, Wolfgang CL, Cameron JL, Boggi U, Yoon DS, Bassi C, Puhan MA, Clavien PA. Benchmarks in Pancreatic Surgery: A Novel Tool for Unbiased Outcome Comparisons. Ann Surg. 2019 Aug;270(2):211-218. doi: 10.1097/SLA.0000000000003223.
Raptis DA, Mettler T, Fischer MA, Patak M, Lesurtel M, Eshmuminov D, de Rougemont O, Graf R, Clavien PA, Breitenstein S. Managing multicentre clinical trials with open source. Inform Health Soc Care. 2014 Mar;39(2):67-80. doi: 10.3109/17538157.2013.812647.
Raptis DA, Sanchez-Velazquez P, Machairas N, Sauvanet A, Rueda de Leon A, Oba A, Groot Koerkamp B, Lovasik B, Chan C, Yeo CJ, Bassi C, Ferrone CR, Kooby D, Moskal D, Tamburrino D, Yoon DS, Barroso E, de Santibanes E, Kauffmann EF, Vigia E, Robin F, Casciani F, Burdio F, Belfiori G, Malleo G, Lavu H, Hartog H, Hwang HK, Han HS, Poves I, Rosado ID, Park JS, Lillemoe KD, Roberts KJ, Sulpice L, Besselink MG, Abuawwad M, Del Chiaro M, de Santibanes M, Falconi M, D'Silva M, Silva M, Abu Hilal M, Qadan M, Sell NM, Beghdadi N, Napoli N, Busch ORC, Mazza O, Muiesan P, Muller PC, Ravikumar R, Schulick R, Powell-Brett S, Abbas SH, Mackay TM, Stoop TF, Gallagher TK, Boggi U, van Eijck C, Clavien PA, Conlon KCP, Fusai GK. Defining Benchmark Outcomes for Pancreatoduodenectomy With Portomesenteric Venous Resection. Ann Surg. 2020 Nov;272(5):731-737. doi: 10.1097/SLA.0000000000004267.
Related Links
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rBiostatistics.com - Cloud Graphical User Interface for R Statistics and eLearning Platform
The Comprehensive Complications Index® (CCI®)
Other Identifiers
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WB-08-2019
Identifier Type: -
Identifier Source: org_study_id