Pancreatic NeoplasmsNCT04053998
Benchmarking Outcomes in Pancreatic Surgery - WhippleBenchmarks.Org
An observational study of Pancreatic Neoplasms and Pancreaticoduodenectomy, run by Royal Free Hospital NHS Foundation Trust at 2 sites in 2 countries.
Trial summary
The WhippleBenchmark 2 Collaborative study aims at defining benchmark criteria for best achievable outcomes after pancreaticoduodenectomy with portal vein resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms, Pancreaticoduodenectomy
- What is being tested?
- Pancreaticoduodenectomy with portal vein resection
- Type of treatment
- Surgery or procedure
- How many people
- 1,462 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 9 Aug 2019to 20 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pancreatic malignancy that underwent open pancreaticoduodenectomy with portal vein resection.
Who may be able to join
- Adults ≥ 18 years
- Resectable malignant or benign diseases (i.e. all indications)
- Open pancreaticoduodenectomy (all techniques allowed) with concurrent portal vein resection
Who cannot join
- Patients < 18 years
- Pancreatic resections other than pancreaticoduodenectomy and portal vein resection
- Pancreaticoduodenectomy with arterial reconstruction
- Laparoscopic or robotic pancreaticoduodenectomy
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
Read the 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.
- Conditions
- Pancreatic Neoplasms, Pancreaticoduodenectomy
- Being tested
- Pancreaticoduodenectomy with portal vein resection
- Keywords
- Pancreaticoduodenectomy, Portal vein resection, Benchmarks, Outcomes
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreaticoduodenectomy with portal vein resectionProcedure or surgery
Pancreatic surgery with vein resection to achieve disease clearance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
Death due to any cause postoperatively
Measured: 12 months
Morbidity rate
Classified according to the Clavien-Dindo Classification of postoperative complications.
Measured: 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).
Measured: 12 months
Secondary outcomes (3)
Pancreatic fistula rates
reported according to both the International Study Group of Pancreatic Fistula (ISGPF) and Clavien-Dindo classification.
Measured: 12 months
Hospital readmission rate
Any hospital readmission to the primary or other peripheral hospitals
Measured: 12 months
Disease free survival rate
Disease recurrence
Measured: Up to 10 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start9 Aug 2019
- Primary completion10 Feb 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,462 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Free Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- 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, San Raffaele University Hospital, Italy, St Vincent's University Hospital, 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
- Responsible party
- Principal investigator, Dimitri Raptis, Royal Free Hospital NHS Foundation Trust
- Investigators
- Giuseppe K Fusai, MD, Principal investigator, Royal Free Hospital, London, UKDimitri A Raptis, MD, MSc, PhD, Principal investigator, Royal Free Hospital, London, UKPatricia Sánchez Velázquez, MD, PhD, Principal investigator, Parc de Salut Mar, Barcelona, SpainNikolaos Machairas, MD, Principal investigator, Royal Free Hospital, London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053998
- Sponsor's protocol ID
- WB-08-2019
- Status last verified
- Nov 2020
- First submitted
- 9 Aug 2019
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 30829701Raptis 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.
PubMed 24517456Raptis 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.
PubMed 32889866
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benchmarking Outcomes in Pancreatoduodenectomy With Portal Vein Resection - WhippleBenchmarks.Org
- ClinicalTrials.gov ID
- NCT04053998
- Acronym / sponsor ID
- WB-08-2019
- Conditions
- Pancreatic Neoplasms, Pancreaticoduodenectomy
- Keywords
- Pancreaticoduodenectomy, Portal vein resection, Benchmarks, Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,462 participants (actual)
- Lead sponsor
- Royal Free Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- 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, San Raffaele University Hospital, Italy, St Vincent's University Hospital, 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
- Study start
- 9 Aug 2019 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pancreatic malignancy that underwent open pancreaticoduodenectomy with portal vein resection.
Key inclusion criteria (3 listed)
- Adults ≥ 18 years
- Resectable malignant or benign diseases (i.e. all indications)
- Open pancreaticoduodenectomy (all techniques allowed) with concurrent portal vein resection
Key exclusion criteria (4 listed)
- Patients < 18 years
- Pancreatic resections other than pancreaticoduodenectomy and portal vein resection
- Pancreaticoduodenectomy with arterial reconstruction
- Laparoscopic or robotic pancreaticoduodenectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pancreaticoduodenectomy with portal vein resectionPancreatic surgery with vein resection to achieve disease clearance. | Procedure or surgery | – |
Primary outcome
Mortality rate
Time frame: 12 months
Death due to any cause postoperatively
Morbidity rate
Time frame: 12 months
Classified according to the Clavien-Dindo Classification of postoperative complications.
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).
3 secondary outcomes
Pancreatic fistula rates
Time frame: 12 months
Hospital readmission rate
Time frame: 12 months
Disease free survival rate
Time frame: Up to 10 years postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Background: PubMed 30829701Sanchez-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.
- Background: PubMed 24517456Raptis 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.
- Derived from this study: PubMed 32889866Raptis 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.
- rBiostatistics.com - Cloud Graphical User Interface for R Statistics and eLearning PlatformLink provided by the sponsor.
- The Comprehensive Complications Index® (CCI®)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe K Fusai, MD principal investigator
Royal Free Hospital, London, UK
Dimitri A Raptis, MD, MSc, PhD principal investigator
Royal Free Hospital, London, UK
Patricia Sánchez Velázquez, MD, PhD principal investigator
Parc de Salut Mar, Barcelona, Spain
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neoplasms and Pancreaticoduodenectomy, run by Royal Free Hospital NHS Foundation Trust at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04053998, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020; AzTrials last refreshed its copy on 3 Nov 2026.