Prospective Evaluation of the Resection Margins and the Ganglionic Status Using a Quality Standard Resection for Adenocarcinoma of the Head of the Pancreas
MRP
2 other identifiers
interventional
156
1 country
20
Brief Summary
This multicentric prospective study evaluates the role of the margins resection and the ganglionic status when using a quality standard for the resection of adenocarcinoma of the head of the pancreas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2008
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 9, 2009
CompletedFirst Posted
Study publicly available on registry
June 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedMarch 20, 2015
March 1, 2013
3.8 years
June 9, 2009
March 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prognostic value of the invasion of the margins measured in millimetres on the overall survival
4 years
Secondary Outcomes (1)
Relapse free survival: time between surgery and relapse or a right censure. The relapse is determined by clinical examination, biologic examination and imaging, which reveals metastasis or an isolated local relapse
4 years
Study Arms (1)
resection for adenocarcinoma
EXPERIMENTALquality standard resection for adenocarcinoma of the head of the pancreas
Interventions
quality standard for the resection of adenocarcinoma of the head of the pancreas
Eligibility Criteria
You may qualify if:
- A head of the pancreas tumor compatible with adenocarcinoma diagnosis
- tumor apparently removable
- patient aged from 18 to older
- signed consent
- pregnancy, breast feeding
- patient in an urgency situation or patient with legal protection
You may not qualify if:
- tumor other than adenocarcinoma of the head of the pancreas.
- analysis of the margins not done with the defined criteria
- nonadhesion to the surgical protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Chu D'Angers
Angers, France
Chu de Bordeaux
Bordeaux, France
Hopital Ambroise Pare
Boulogne, France
Chu de Clermont-Ferrand
Clermont-Ferrand, France
Hopital Beaujon
Clichy, France
Hopital Henri Mondor
Créteil, France
Hopital de L'Antiquaille
Lyon, France
Hopital de La Croix-Rousse
Lyon, France
Hospices Civils de Lyon
Lyon, France
Chu La Conception
Marseille, France
Institut Paoli-Calmettes
Marseille, France
Centre Val D'Aurelle Paul Lamarque
Montpellier, France
Hotel Dieu
Nantes, France
Hopital Cochin
Paris, France
Hopital Pitie-Salpetriere
Paris, France
Hopital Tenon
Paris, France
Hopitial Saint Antoine
Paris, France
Hopital Pontchaillou
Rennes, France
Hopitaux Universitaires de Strasbourg
Strasbourg, France
Chu Purpan
Toulouse, France
Related Publications (2)
Delpero JR, Jeune F, Bachellier P, Regenet N, Le Treut YP, Paye F, Carrere N, Sauvanet A, Adham M, Autret A, Poizat F, Turrini O, Boher JM. Prognostic Value of Resection Margin Involvement After Pancreaticoduodenectomy for Ductal Adenocarcinoma: Updates From a French Prospective Multicenter Study. Ann Surg. 2017 Nov;266(5):787-796. doi: 10.1097/SLA.0000000000002432.
PMID: 28953554DERIVEDDelpero JR, Bachellier P, Regenet N, Le Treut YP, Paye F, Carrere N, Sauvanet A, Autret A, Turrini O, Monges-Ranchin G, Boher JM. Pancreaticoduodenectomy for pancreatic ductal adenocarcinoma: a French multicentre prospective evaluation of resection margins in 150 evaluable specimens. HPB (Oxford). 2014 Jan;16(1):20-33. doi: 10.1111/hpb.12061. Epub 2013 Mar 7.
PMID: 23464850DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean Robert DELPERO, PhD
Institut Paoli-Calmettes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2009
First Posted
June 11, 2009
Study Start
August 1, 2008
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
March 20, 2015
Record last verified: 2013-03