Benchmarking Outcomes in Pancreatic Surgery - WhippleBenchmarks.Org

Study Overview
=================
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.

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

Conditions
-----------------
Pancreatic Neoplasms, Pancreaticoduodenectomy

Intervention / Treatment
-----------------
* Procedure: Pancreaticoduodenectomy with portal vein resection


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Pancreaticoduodenectomy with portal vein resection|Pancreatic surgery with vein resection to achieve disease clearance.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 12 months | 
| Disease free survival rate | Disease recurrence | Up to 10 years postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreaticoduodenectomy, Portal vein resection, Benchmarks, Outcomes