Prospective Evaluation of the Resection Margins and the Ganglionic Status Using a Quality Standard Resection for Adenocarcinoma of the Head of the Pancreas - Full Text View

Sponsor:	Institut Paoli-Calmettes
Information provided by:	Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:	NCT00918853

Purpose

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.

Condition	Intervention
Pancreas Adenocarcinoma	Procedure: resection of adenocarcinoma of the head of the pancreas

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
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.

Resource links provided by NLM:

Drug Information available for: Pancrelipase Ultrase

U.S. FDA Resources

Further study details as provided by Institut Paoli-Calmettes:

Primary Outcome Measures:

Prognostic value of the invasion of the margins measured in millimetres on the overall survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	156
Study Start Date:	August 2008
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
resection for adenocarcinoma: Experimental quality standard resection for adenocarcinoma of the head of the pancreas	Procedure: resection of adenocarcinoma of the head of the pancreas quality standard for the resection of adenocarcinoma of the head of the pancreas

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00918853

Contacts

Contact: Dominique GENRE, MD	(33)4 91 22 37 78	bec@marseille.fnclcc.fr
Contact: Agnès BOYER CHAMMARD, MD	(33)4 91 22 37 78	bec@marseille.fnclcc.fr

Locations

France
Institut Paoli-calmettes	Recruiting
MARSEILLE, France
Contact: Jean-Robert DELPERO, PhD
Hopital Tenon	Recruiting
PARIS, France
Contact: Thierry ANDRE, PhD
Hopitial Saint Antoine	Recruiting
PARIS, France
Contact: Francois PAYE, PhD
Hopital Beaujon	Recruiting
CLICHY, France
Contact: Alain SAUVANET, PhD
Chu De Bordeaux	Recruiting
BORDEAUX, France
Contact: Bernard MASSON, MD
Hospices Civils De Lyon	Recruiting
LYON, France
Contact: Christian PARTENSKY, PhD
Hopital Pitie-salpetriere	Recruiting
PARIS, France
Contact: Jean-Christophe VAILLANT, PhD
Hopital Henri Mondor	Recruiting
CRETEIL, France
Contact: Daniel CHERQUI, MD
CHU PURPAN	Recruiting
TOULOUSE, France
Contact: Nicolas CARRERE, MD
Centre Val D'Aurelle Paul Lamarque	Recruiting
MONTPELLIER, France
Contact: Philippe ROUANET, PhD
Chu La Conception	Recruiting
MARSEILLE, France
Contact: Yves-Patrice LE TREUT, PhD
HOTEL DIEU	Recruiting
NANTES, France
Contact: Sylvie METAIRIE, MD
Hopital Pontchaillou	Recruiting
RENNES, France
Contact: Bernard MEUNIER, MD
Hopital Cochin	Recruiting
PARIS, France
Contact: Benoit TERRIS, PhD
Hopital Ambroise Pare	Recruiting
BOULOGNE, France
Contact: Bernard NORDLINGER, PhD
Hopital De L'Antiquaille	Recruiting
LYON, France
Contact: Jean-Louis PEIX, PhD
Hopitaux Universitaires De Strasbourg	Recruiting
STRASBOURG, France
Contact: Philippe BACHELLIER, PhD
Chu De Clermont-ferrand	Recruiting
CLERMONT-FERRAND, France
Contact: CHIPPONI, PhD
Hopital De La Croix-rousse	Recruiting
LYON, France
Contact: Jacques BEAULIEUX, PhD
Chu D'Angers	Recruiting
ANGERS, France
Contact: Jean-Pierre ARNAUD, PhD

Sponsors and Collaborators

Institut Paoli-Calmettes

Investigators

Principal Investigator:

Jean Robert DELPERO, PhD

Institut Paoli-Calmettes

More Information

Additional Information:

OFFICIAL WEB SITE OF THE SPONSOR This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Institut Paoli-Calmettes ( Jean Robert DELPERO )
Study ID Numbers:	MRP/IPC 2007-005, ID-RCB 2007-A01326-47
Study First Received:	June 9, 2009
Last Updated:	June 10, 2009
ClinicalTrials.gov Identifier:	NCT00918853 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Institut Paoli-Calmettes:

pancreas
adenocarcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Therapeutic Uses
Gastrointestinal Agents
Adenocarcinoma

Pancrelipase
Pharmacologic Actions
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on February 08, 2010