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Spots Global Cancer Trial Database for Benchmarking Outcomes in Pancreatic Surgery - WhippleBenchmarks.Org

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Trial Identification

Brief Title: Benchmarking Outcomes in Pancreatic Surgery - WhippleBenchmarks.Org

Official Title: Benchmarking Outcomes in Pancreatoduodenectomy With Portal Vein Resection - WhippleBenchmarks.Org

Study ID: NCT04053998

Study Description

Brief Summary: The WhippleBenchmark 2 Collaborative study aims at defining benchmark criteria for best achievable outcomes after pancreaticoduodenectomy with portal vein resection.

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Parc de Salut Mar, Barcelona, , Spain

Royal Free Hospital, London, , United Kingdom

Contact Details

Name: Giuseppe K Fusai, MD

Affiliation: Royal Free Hospital, London, UK

Role: PRINCIPAL_INVESTIGATOR

Name: Dimitri A Raptis, MD, MSc, PhD

Affiliation: Royal Free Hospital, London, UK

Role: PRINCIPAL_INVESTIGATOR

Name: Patricia Sánchez Velázquez, MD, PhD

Affiliation: Parc de Salut Mar, Barcelona, Spain

Role: PRINCIPAL_INVESTIGATOR

Name: Nikolaos Machairas, MD

Affiliation: Royal Free Hospital, London, UK

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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