Clinical trial NCT04053998: Benchmarking Outcomes in Pancreatic Surgery - WhippleBenchmarks.Org
Official title: Benchmarking Outcomes in Pancreatoduodenectomy With Portal Vein Resection - WhippleBenchmarks.Org
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Neoplasms
Pancreaticoduodenectomy
Keywords: Pancreaticoduodenectomy
Portal vein resection
Benchmarks
Outcomes
Lead sponsor: Royal Free Hospital NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
name: Cancer Institute Hospital, Japan
name: Hospital Curry Cabral, CHLC, Lisbon, Portugal
name: St. Joseph's Hospital of Atlanta
name: Erasmus Medical Center
name: Hospital Italiano de Buenos Aires
name: Juntendo University
name: Parc de Salut Mar
name: Queen Elizabeth Hospital NHS Foundation Trust
name: Rennes University Hospital, Rennes, France
name: San Raffaele University Hospital, Italy
name: St. Vincent's University Hospital, Dublin, Ireland
name: Thomas Jefferson University
name: University of Dublin, Trinity College
name: University of Lyon
name: Mainz University
name: University of Pisa
name: Azienda Ospedaliera Universitaria Integrata Verona
name: University Hospital Southampton NHS Foundation Trust
name: University Hospital, Zürich
name: Amsterdam UMC, location VUmc
name: University of Colorado, Denver
name: Severance Hospital
First posted: 2019-08-13
Enrollment: 1462
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pancreatic malignancy that underwent open pancreaticoduodenectomy with portal vein resection.

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 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

Primary outcomes:
measure: Mortality rate
timeFrame: 12 months
measure: Morbidity rate
timeFrame: 12 months
measure: Morbidity assessed according to the Comprehensive Complications Index® (CCI®)
timeFrame: 12 months
Secondary outcomes:
measure: Pancreatic fistula rates
timeFrame: 12 months
measure: Hospital readmission rate
timeFrame: 12 months
measure: Disease free survival rate
timeFrame: Up to 10 years postoperatively
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Parc de Salut Mar
city: London
country: United Kingdom
facility: Royal Free Hospital
Study officials:
affiliation: Royal Free Hospital, London, UK
name: Giuseppe K Fusai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Free Hospital, London, UK
name: Dimitri A Raptis, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Parc de Salut Mar, Barcelona, Spain
name: Patricia Sánchez Velázquez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Free Hospital, London, UK
name: Nikolaos Machairas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sanchez-Velazquez P, Muller X, Malleo G, Park JS, Hwang HK, Napoli N, Javed AA, Inoue Y, Beghdadi N, Kalisvaart M, Vigia E, Walsh CD, Lovasik B, Busquets J, Scandavini C, Robin F, Yoshitomi H, Mackay TM, Busch OR, Hartog H, Heinrich S, Gleisner A, Perinel J, Passeri M, Lluis N, Raptis DA, Tschuor C, Oberkofler CE, DeOliveira ML, Petrowsky H, Martinie J, Asbun H, Adham M, Schulick R, Lang H, Koerkamp BG, Besselink MG, Han HS, Miyazaki M, Ferrone CR, Fernandez-Del Castillo C, Lillemoe KD, Sulpice L, Boudjema K, Del Chiaro M, Fabregat J, Kooby DA, Allen P, Lavu H, Yeo CJ, Barroso E, Roberts K, Muiesan P, Sauvanet A, Saiura A, Wolfgang CL, Cameron JL, Boggi U, Yoon DS, Bassi C, Puhan MA, Clavien PA. Benchmarks in Pancreatic Surgery: A Novel Tool for Unbiased Outcome Comparisons. Ann Surg. 2019 Aug;270(2):211-218. doi: 10.1097/SLA.0000000000003223.
citation: Raptis DA, Mettler T, Fischer MA, Patak M, Lesurtel M, Eshmuminov D, de Rougemont O, Graf R, Clavien PA, Breitenstein S. Managing multicentre clinical trials with open source. Inform Health Soc Care. 2014 Mar;39(2):67-80. doi: 10.3109/17538157.2013.812647.
citation: Raptis DA, Sanchez-Velazquez P, Machairas N, Sauvanet A, Rueda de Leon A, Oba A, Groot Koerkamp B, Lovasik B, Chan C, Yeo CJ, Bassi C, Ferrone CR, Kooby D, Moskal D, Tamburrino D, Yoon DS, Barroso E, de Santibanes E, Kauffmann EF, Vigia E, Robin F, Casciani F, Burdio F, Belfiori G, Malleo G, Lavu H, Hartog H, Hwang HK, Han HS, Poves I, Rosado ID, Park JS, Lillemoe KD, Roberts KJ, Sulpice L, Besselink MG, Abuawwad M, Del Chiaro M, de Santibanes M, Falconi M, D'Silva M, Silva M, Abu Hilal M, Qadan M, Sell NM, Beghdadi N, Napoli N, Busch ORC, Mazza O, Muiesan P, Muller PC, Ravikumar R, Schulick R, Powell-Brett S, Abbas SH, Mackay TM, Stoop TF, Gallagher TK, Boggi U, van Eijck C, Clavien PA, Conlon KCP, Fusai GK. Defining Benchmark Outcomes for Pancreatoduodenectomy With Portomesenteric Venous Resection. Ann Surg. 2020 Nov;272(5):731-737. doi: 10.1097/SLA.0000000000004267.