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Completed

NCT Number: NCT04053998

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Parc de Salut Mar, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pancreaticoduodenectomy with portal vein resection

Procedure

Pancreatic surgery with vein resection to achieve disease clearance.

Primary outcomes

  1. Mortality rate

    Time frame: 12 months

    Death due to any cause postoperatively

  2. Morbidity rate

    Time frame: 12 months

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

  3. Morbidity assessed according to the Comprehensive Complications Index® (CCI®)

    Time frame: 12 months

    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).

Secondary outcomes

  1. Pancreatic fistula rates

    Time frame: 12 months

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

  2. Hospital readmission rate

    Time frame: 12 months

    Any hospital readmission to the primary or other peripheral hospitals

  3. Disease free survival rate

    Time frame: Up to 10 years postoperatively

    Disease recurrence

Sponsors and collaborators

Lead sponsor

Royal Free Hospital NHS Foundation Trust

Other

Collaborators

  • Amsterdam UMC, location VUmc
  • 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
  • Mainz University
  • Parc de Salut Mar
  • Queen Elizabeth Hospital NHS Foundation Trust
  • Rennes University Hospital
  • San Raffaele University Hospital, Italy
  • Seoul National University Bundang Hospital
  • Severance Hospital
  • St Vincent's University Hospital, Ireland
  • St. Joseph's Hospital of Atlanta
  • 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

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 13, 2019
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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