Benchmarking Outcomes in Pancreatic Surgery - WhippleBenchmarks.Org
Study Details
Study Description
Brief Summary
The WhippleBenchmark 2 Collaborative study aims at defining benchmark criteria for best achievable outcomes after pancreaticoduodenectomy with portal vein resection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Pancreatoduodenectomy (PD) with portal vein resection (PVR) is performed for the achievement of complete resection (R0) in patients with locally advanced pancreatic head lesions. Despite most commonly performed in high-volume pancreatic surgery centers by experienced surgeons, best achievable outcomes, such as morbidity and mortality, following such complex procedure remain unknown.
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Mortality rate [12 months]
Death due to any cause postoperatively
- Morbidity rate [12 months]
Classified according to the Clavien-Dindo Classification of postoperative complications.
- Morbidity assessed according to the Comprehensive Complications Index® (CCI®) [12 months]
The Comprehensive Complications Index® (CCI®) reports the cumulative postoperative morbidity, a novel metric which measures the overall morbidity on a scale from 0 (no complications) to 100 (death).
Secondary Outcome Measures
- Pancreatic fistula rates [12 months]
reported according to both the International Study Group of Pancreatic Fistula (ISGPF) and Clavien-Dindo classification.
- Hospital readmission rate [12 months]
Any hospital readmission to the primary or other peripheral hospitals
- Disease free survival rate [Up to 10 years postoperatively]
Disease recurrence
Eligibility Criteria
Criteria
Center Eligibility Criteria
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High volume centers from ≥3 continents
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Minimum 50 cases of pancreatic surgery per year or 150 cases within 3 years
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Published in the area of pancreas surgery
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Prospective database available
Patient Eligibility Criteria
Inclusion Criteria:
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Adults ≥ 18 years
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Resectable malignant or benign diseases (i.e. all indications)
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Open pancreaticoduodenectomy (all techniques allowed) with concurrent portal vein resection
Exclusion Criteria:
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Patients < 18 years
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Pancreatic resections other than pancreaticoduodenectomy and portal vein resection
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Pancreaticoduodenectomy with arterial reconstruction
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Laparoscopic or robotic pancreaticoduodenectomy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Parc de Salut Mar | Barcelona | Spain | 08003 | |
| 2 | Royal Free Hospital | London | United Kingdom | NW3 2QG |
Sponsors and Collaborators
- Royal Free Hospital NHS Foundation Trust
- Seoul National University Bundang Hospital
- Cancer Institute Hospital, Japan
- Hospital Curry Cabral, CHLC, Lisbon, Portugal
- St. Joseph's Hospital of Atlanta
- Erasmus Medical Center
- Hospital Italiano de Buenos Aires
- Juntendo University
- Parc de Salut Mar
- Queen Elizabeth Hospital NHS Foundation Trust
- Rennes University Hospital, Rennes, France
- San Raffaele University Hospital, Italy
- St. Vincent's University Hospital, Dublin, Ireland
- Thomas Jefferson University
- University of Dublin, Trinity College
- University of Lyon
- Mainz University
- University of Pisa
- Azienda Ospedaliera Universitaria Integrata Verona
- University Hospital Southampton NHS Foundation Trust
- University Hospital, Zürich
- Amsterdam UMC, location VUmc
- University of Colorado, Denver
- Severance Hospital
Investigators
- Principal Investigator: Giuseppe K Fusai, MD, Royal Free Hospital, London, UK
- Principal Investigator: Dimitri A Raptis, MD, MSc, PhD, Royal Free Hospital, London, UK
- Principal Investigator: Patricia Sánchez Velázquez, MD, PhD, Parc de Salut Mar, Barcelona, Spain
- Principal Investigator: Nikolaos Machairas, MD, Royal Free Hospital, London, UK
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- rBiostatistics.com - Cloud Graphical User Interface for R Statistics and eLearning Platform
- The Comprehensive Complications Index® (CCI®)
Publications
- 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.
- Sánchez-Velázquez 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, Fernández-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.
- WB-08-2019