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| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
| Cancer Institute Hospital, Japan | OTHER |
| Hospital Curry Cabral, CHLC, Lisbon, Portugal | UNKNOWN |
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The WhippleBenchmark 2 Collaborative study aims at defining benchmark criteria for best achievable outcomes after pancreaticoduodenectomy with portal vein resection.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pancreaticoduodenectomy with portal vein resection | Procedure | Pancreatic surgery with vein resection to achieve disease clearance. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate | Death due to any cause postoperatively | 12 months |
| Morbidity rate | Classified according to the Clavien-Dindo Classification of postoperative complications. | 12 months |
| Morbidity assessed according to the Comprehensive Complications Index® (CCI®) | 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). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pancreatic fistula rates | reported according to both the International Study Group of Pancreatic Fistula (ISGPF) and Clavien-Dindo classification. | 12 months |
| Hospital readmission rate | Any hospital readmission to the primary or other peripheral hospitals |
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Center Eligibility Criteria
Patient Eligibility Criteria
Inclusion Criteria:
Exclusion Criteria:
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Patients with pancreatic malignancy that underwent open pancreaticoduodenectomy with portal vein resection.
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parc de Salut Mar | Barcelona | 08003 | Spain | |||
| Royal Free Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30829701 | Background | 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. | |
| 24517456 |
| Label | URL |
|---|---|
| rBiostatistics.com - Cloud Graphical User Interface for R Statistics and eLearning Platform | View source |
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The study Investigators will act as the custodians of the data. The data however belong to all collaborators. The study investigators will decide after the publication of the main report about requests from the collaborators regarding secondary analyses and will consider all such requests based on quality and the validity of the proposed project.
The data will remain available to share with the collaborators as described above up to 5 years after the study completion.
Quality and validity of the proposed project.
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D016577 | Pancreaticoduodenectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| 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 | OTHER |
| San Raffaele University Hospital, Italy | OTHER |
| St Vincent's University Hospital, Ireland | OTHER |
| 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 |
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| 12 months |
| Disease free survival rate | Disease recurrence | Up to 10 years postoperatively |
| London |
| NW3 2QG |
| United Kingdom |
| Background |
| 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. |
| 32889866 | Derived | 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. |
| The Comprehensive Complications Index® (CCI®) | View source |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |