Prospective Evaluation of the Resection Margins and the Ganglionic Status Using a Quality Standard Resection for Adenocarcinoma of the Head of the Pancreas
Information source: Institut Paoli-Calmettes
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreas; Adenocarcinoma
Intervention: resection of adenocarcinoma of the head of the pancreas (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: Institut Paoli-Calmettes Official(s) and/or principal investigator(s):
Jean Robert DELPERO, PhD, Principal Investigator, Affiliation: Institut Paoli-Calmettes
Overall contact:
Dominique GENRE, MD, Phone: (33)4 91 22 37 78, Email: bec@marseille.fnclcc.fr
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.
Clinical Details
Official title: Prospective Evaluation of the Resection Margins and the Ganglionic Status Using a Quality Standard Resection for Adenocarcinoma of the Head of the Pancreas.
Study design: Treatment, Open Label, Single Group Assignment, Efficacy Study
Primary outcome: Prognostic value of the invasion of the margins measured in millimetres on the overall survival
Secondary outcome: 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
Detailed description:
Primary objective:
- Evaluation of the prognosis role of the invasion of the margins on the overall survival
after a standard resection of adenocarcinoma of the head of the pancreas.
Secondary objectives:
- Evaluation of the prognosis role of the invasion:
- Of margins on the overall survival.
- Of each margins (distal pancreatic margin, gastric, posterior, retro-venous,
retro-arterial) on the overall survival.
- Of the ganglionic group of the superior mesenteric artery and the other nodes.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- A head of the pancreas tumor compatible with adenocarcinoma diagnosis
- tumor apparently removable
- patient aged from 18 to older
- signed consent
Non inclusion criteria:
- pregnancy, breast feeding
- patient in an urgency situation or patient with legal protection
Exclusion Criteria after surgery:
- 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
Locations and Contacts
Dominique GENRE, MD, Phone: (33)4 91 22 37 78, Email: bec@marseille.fnclcc.fr
Institut Paoli-calmettes, MARSEILLE, France; Recruiting
Jean-Robert DELPERO, PhD
Hopital Tenon, PARIS, France; Recruiting
Thierry ANDRE, PhD
Hopitial Saint Antoine, PARIS, France; Recruiting
Francois PAYE, PhD
Hopital Beaujon, CLICHY, France; Recruiting
Alain SAUVANET, PhD
Chu De Bordeaux, BORDEAUX, France; Recruiting
Bernard MASSON, MD
Hospices Civils De Lyon, LYON, France; Recruiting
Christian PARTENSKY, PhD
Hopital Pitie-salpetriere, PARIS, France; Recruiting
Jean-Christophe VAILLANT, PhD
Hopital Henri Mondor, CRETEIL, France; Recruiting
Daniel CHERQUI, MD
CHU PURPAN, TOULOUSE, France; Recruiting
Nicolas CARRERE, MD
Centre Val D'Aurelle Paul Lamarque, MONTPELLIER, France; Recruiting
Philippe ROUANET, PhD
Chu D'Angers, ANGERS, France; Recruiting
Jean-Pierre ARNAUD, PhD
HOTEL DIEU, NANTES, France; Recruiting
Sylvie METAIRIE, MD
Hopital Pontchaillou, RENNES, France; Recruiting
Bernard MEUNIER, MD
Hopital Cochin, PARIS, France; Recruiting
Benoit TERRIS, PhD
Hopital Ambroise Pare, BOULOGNE, France; Recruiting
Bernard NORDLINGER, PhD
Hopital De L'Antiquaille, LYON, France; Recruiting
Jean-Louis PEIX, PhD
Hopitaux Universitaires De Strasbourg, STRASBOURG, France; Recruiting
Philippe BACHELLIER, PhD
Chu De Clermont-ferrand, CLERMONT-FERRAND, France; Recruiting
CHIPPONI, PhD
Hopital De La Croix-rousse, LYON, France; Recruiting
Jacques BEAULIEUX, PhD
Chu La Conception, MARSEILLE, France; Recruiting
Yves-Patrice LE TREUT, PhD
Additional Information
OFFICIAL WEB SITE OF THE SPONSOR
Starting date: August 2008
Ending date: August 2012
Last updated: June 10, 2009
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