Pancreatic Neoplasms, Pancreaticoduodenectomy
Conditions
Keywords
Pancreaticoduodenectomy, Portal vein resection, Benchmarks, Outcomes
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.
Interventions
PROCEDUREPancreaticoduodenectomy with portal vein resection
Pancreatic surgery with vein resection to achieve disease clearance.
Sponsors
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, 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
Royal Free Hospital NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Center Eligibility Criteria * High volume centers from ≥3 continents * Minimum 50 cases of pancreatic surgery per year or 150 cases within 3 years * Published in the area of pancreas surgery * Prospective database available Patient Eligibility Criteria Inclusion Criteria: * Adults ≥ 18 years * Resectable malignant or benign diseases (i.e. all indications) * Open pancreaticoduodenectomy (all techniques allowed) with concurrent portal vein resection
Exclusion criteria
* Patients \< 18 years * Pancreatic resections other than pancreaticoduodenectomy and portal vein resection * Pancreaticoduodenectomy with arterial reconstruction * Laparoscopic or robotic pancreaticoduodenectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain, United Kingdom
Outcome results
None listed