Benchmarking Outcomes in Pancreatic Surgery - WhippleBenchmarks.Org

Royal Free Hospital NHS Foundation Trust1,462 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

1,462

Conditions

Pancreatic Neoplasms Pancreaticoduodenectomy

Interventions

Pancreaticoduodenectomy with portal vein resectionPROCEDURE

Pancreatic surgery with vein resection to achieve disease clearance.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Parc de Salut Mar

Barcelona, Spain

Royal Free Hospital

London, United Kingdom

Outcomes

Primary Outcomes

Mortality rate

Death due to any cause postoperatively

Time frame: 12 months

Morbidity rate

Classified according to the Clavien-Dindo Classification of postoperative complications.

Time frame: 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).

Time frame: 12 months

Secondary Outcomes

Pancreatic fistula rates

reported according to both the International Study Group of Pancreatic Fistula (ISGPF) and Clavien-Dindo classification.

Time frame: 12 months

Hospital readmission rate

Any hospital readmission to the primary or other peripheral hospitals

Time frame: 12 months

Disease free survival rate

Disease recurrence

Time frame: Up to 10 years postoperatively

Data from ClinicalTrials.gov

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