Benchmarking Outcomes in Pancreatic Surgery - WhippleBenchmarks.Org
1 other identifier
observational
1,462
2 countries
2
Brief Summary
The WhippleBenchmark 2 Collaborative study aims at defining benchmark criteria for best achievable outcomes after pancreaticoduodenectomy with portal vein resection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2019
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2019
CompletedStudy Start
First participant enrolled
August 9, 2019
CompletedFirst Posted
Study publicly available on registry
August 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2020
CompletedNovember 20, 2020
November 1, 2020
6 months
August 9, 2019
November 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (3)
Pancreatic fistula rates
12 months
Hospital readmission rate
12 months
Disease free survival rate
Up to 10 years postoperatively
Interventions
Pancreatic surgery with vein resection to achieve disease clearance.
Eligibility Criteria
Patients with pancreatic malignancy that underwent open pancreaticoduodenectomy with portal vein resection.
You may qualify if:
- Adults ≥ 18 years
- Resectable malignant or benign diseases (i.e. all indications)
- Open pancreaticoduodenectomy (all techniques allowed) with concurrent portal vein resection
You may not qualify if:
- Patients \< 18 years
- Pancreatic resections other than pancreaticoduodenectomy and portal vein resection
- Pancreaticoduodenectomy with arterial reconstruction
- Laparoscopic or robotic pancreaticoduodenectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royal Free Hospital NHS Foundation Trustlead
- Seoul National University Bundang Hospitalcollaborator
- Cancer Institute Hospital, Japancollaborator
- Hospital Curry Cabral, CHLC, Lisbon, Portugalcollaborator
- St. Joseph's Hospital of Atlantacollaborator
- Erasmus Medical Centercollaborator
- Hospital Italiano de Buenos Airescollaborator
- Juntendo Universitycollaborator
- Parc de Salut Marcollaborator
- Queen Elizabeth Hospital NHS Foundation Trustcollaborator
- Rennes University Hospital, Rennes, Francecollaborator
- San Raffaele University Hospital, Italycollaborator
- St Vincent's University Hospital, Irelandcollaborator
- Thomas Jefferson Universitycollaborator
- University of Dublin, Trinity Collegecollaborator
- University of Lyoncollaborator
- Mainz Universitycollaborator
- University of Pisacollaborator
- Azienda Ospedaliera Universitaria Integrata Veronacollaborator
- University Hospital Southampton NHS Foundation Trustcollaborator
- University Hospital, Zürichcollaborator
- Amsterdam UMC, location VUmccollaborator
- University of Colorado, Denvercollaborator
- Severance Hospitalcollaborator
Study Sites (2)
Parc de Salut Mar
Barcelona, 08003, Spain
Royal Free Hospital
London, NW3 2QG, United Kingdom
Related Publications (3)
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.
PMID: 30829701BACKGROUNDRaptis 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.
PMID: 24517456BACKGROUNDRaptis 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.
PMID: 32889866DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Clinical Fellow in HPB and Transplant Surgery
Study Record Dates
First Submitted
August 9, 2019
First Posted
August 13, 2019
Study Start
August 9, 2019
Primary Completion
February 10, 2020
Study Completion
February 20, 2020
Last Updated
November 20, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The data will remain available to share with the collaborators as described above up to 5 years after the study completion.
- Access Criteria
- Quality and validity of the proposed project.
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.