Benchmarking Outcomes in Pancreatic Surgery - WhippleBenchmarks.Org

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

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

Study Overview

• Status: Completed
• Conditions: Pancreatic Neoplasms; Pancreaticoduodenectomy
• Intervention / Treatment: Procedure: 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.

• Study Type: Observational
• Enrollment (Actual): 1462

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Parc de Salut Mar
• United Kingdom
  • London, United Kingdom, NW3 2QG
    • Royal Free Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with pancreatic malignancy that underwent open pancreaticoduodenectomy with portal vein resection.

Description

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

Study Plan

How is the study designed?

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

Collaborators and Investigators

• Sponsor: Royal Free Hospital NHS Foundation Trust
• Collaborators: University of Colorado, Denver; University of Pisa; Hospital Italiano de Buenos Aires; Parc de Salut Mar; Azienda Ospedaliera Universitaria Integrata Verona; Erasmus Medical Center; Seoul National University Bundang Hospital; Amsterdam UMC, location VUmc; Thomas Jefferson University; University Hospital Southampton NHS Foundation Trust; University Hospital, Zürich; Severance Hospital; University of Dublin, Trinity College; Juntendo University; University of Lyon; Rennes University Hospital, Rennes, France; San Raffaele University Hospital, Italy; Mainz University; Queen Elizabeth Hospital NHS Foundation Trust; Cancer Institute Hospital, Japan; Hospital Curry Cabral, CHLC, Lisbon, Portugal; St. Joseph's Hospital of Atlanta; St. Vincent's University Hospital, Dublin, Ireland
• Investigators: Principal Investigator: Giuseppe K Fusai, MD, Royal Free Hospital, London, UK; Principal Investigator: Dimitri A Raptis, MD, MSc, PhD, Royal Free Hospital, London, UK; Principal Investigator: Patricia Sánchez Velázquez, MD, PhD, Parc de Salut Mar, Barcelona, Spain; Principal Investigator: Nikolaos Machairas, MD, Royal Free Hospital, London, UK

Publications and helpful links

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.

Helpful Links

• rBiostatistics.com - Cloud Graphical User Interface for R Statistics and eLearning Platform
• The Comprehensive Complications Index® (CCI®)

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 9, 2019
• Primary Completion (ACTUAL): February 10, 2020
• Study Completion (ACTUAL): February 20, 2020

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: August 9, 2019
• First Posted (ACTUAL): August 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Outcomes; Pancreaticoduodenectomy; Portal vein resection; Benchmarks
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: WB-08-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study Investigators will act as the custodians of the data. The data however belong to all collaborators. The study investigators will decide after the publication of the main report about requests from the collaborators regarding secondary analyses and will consider all such requests based on quality and the validity of the proposed project.
• IPD Sharing Time Frame: The data will remain available to share with the collaborators as described above up to 5 years after the study completion.
• IPD Sharing Access Criteria: Quality and validity of the proposed project.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No