Pancreaticoduodenectomy with portal vein resection
ProcedurePancreatic surgery with vein resection to achieve disease clearance.
NCT Number: NCT04053998
The WhippleBenchmark 2 Collaborative study aims at defining benchmark criteria for best achievable outcomes after pancreaticoduodenectomy with portal vein resection.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Parc de Salut Mar, Barcelona, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Center Eligibility Criteria
Patient Eligibility Criteria
Inclusion criteria
Exclusion criteria
Pancreatic surgery with vein resection to achieve disease clearance.
Time frame: 12 months
Death due to any cause postoperatively
Time frame: 12 months
Classified according to the Clavien-Dindo Classification of postoperative complications.
Time frame: 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).
Time frame: 12 months
reported according to both the International Study Group of Pancreatic Fistula (ISGPF) and Clavien-Dindo classification.
Time frame: 12 months
Any hospital readmission to the primary or other peripheral hospitals
Time frame: Up to 10 years postoperatively
Disease recurrence
Royal Free Hospital NHS Foundation Trust
Other
Benchmarking Outcomes in Pancreatoduodenectomy With Portal Vein Resection - WhippleBenchmarks.Org
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07703813
Digestive System Diseases, Digestive System Neoplasms
Athens, Attica, Greece
View Trial DetailsNCT02905578
Adenocarcinoma, Cancer of Pancreas
Iowa City, Iowa, United States
View Trial DetailsNCT05512377
Biliary Tract Cancer, Biliary Tract Diseases
Mobile, Alabama, United States
View Trial DetailsNCT05840341
Digestive System Diseases, Digestive System Neoplasms
Beijing, Beijing Municipality, China
View Trial Details