Benchmarking Outcomes in Pancreatic Surgery - WhippleBenchmarks.Org

Pancreatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04053998
• Other study ID #: WB-08-2019
• Status: Completed
• Start date: August 9, 2019
• Est. completion date: February 20, 2020

Study information

• Verified date: November 2020
• Source: Royal Free Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1462
• Est. completion date: February 20, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Pancreaticoduodenectomy

Intervention

Procedure:
• Pancreaticoduodenectomy with portal vein resection
Pancreatic surgery with vein resection to achieve disease clearance.

Locations

Country	Name	City	State
Spain	Parc de Salut Mar	Barcelona
United Kingdom	Royal Free Hospital	London

Sponsors (24)

Lead Sponsor

Collaborator

Royal Free Hospital NHS Foundation Trust

Azienda Ospedaliera Universitaria Integrata Verona, Cancer Institute Hospital, Japan, Erasmus Medical Center, Hospital Curry Cabral, CHLC, Lisbon, Portugal, Hospital Italiano de Buenos Aires, Juntendo University Hospital, Mainz University, Parc de Salut Mar, Queen Elizabeth Hospital NHS Foundation Trust, Rennes University Hospital, Rennes, France, San Raffaele University Hospital, Italy, Seoul National University Bundang Hospital, Severance Hospital, St. Joseph's Hospital of Atlanta, St. Vincent's University Hospital, Dublin, Ireland, Thomas Jefferson University, University Hospital Southampton NHS Foundation Trust, University Hospital, Zürich, University of Colorado, Denver, University of Dublin, Trinity College, University of Lyon, University of Pisa, VU University Medical Center

Countries where clinical trial is conducted

Spain,  United Kingdom, 

References & Publications (2)

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. — View Citation

Sánchez-Velázquez 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, Fernández-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate	Death due to any cause postoperatively	12 months
Primary	Morbidity rate	Classified according to the Clavien-Dindo Classification of postoperative complications.	12 months
Primary	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	Pancreatic fistula rates	reported according to both the International Study Group of Pancreatic Fistula (ISGPF) and Clavien-Dindo classification.	12 months
Secondary	Hospital readmission rate	Any hospital readmission to the primary or other peripheral hospitals	12 months
Secondary	Disease free survival rate	Disease recurrence	Up to 10 years postoperatively

External Links

•   rBiostatistics.com - Cloud Graphical User Interface for R Statistics and eLearning Platform
•   The Comprehensive Complications Index® (CCI®)
•   The official WhippleBenchmarks.org Study data entry management system