Benchmarking Outcomes In Pancreatic Surgery - WhippleBenchmarks.Org

Study Overview

Benchmarking Outcomes in Pancreatic Surgery - WhippleBenchmarks.Org

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.

Pancreatic Neoplasms
Pancreaticoduodenectomy

PROCEDURE: Pancreaticoduodenectomy with portal vein resection

WB-08-2019

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-08-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-11-18
First Submitted that Met QC Criteria 2019-08-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-11-20
First Posted (ACTUAL) 2019-08-13	Results First Posted N/A	Last Verified 2020-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Adults ≥ 18 years
Resectable malignant or benign diseases (i.e. all indications)
Open pancreaticoduodenectomy (all techniques allowed) with concurrent portal vein resection

Patients < 18 years
Pancreatic resections other than pancreaticoduodenectomy and portal vein resection
Pancreaticoduodenectomy with arterial reconstruction
Laparoscopic or robotic pancreaticoduodenectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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, Dublin, 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

Investigators

PRINCIPAL_INVESTIGATOR: Giuseppe K Fusai, MD, Royal Free Hospital, London, UK

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
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.
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.

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