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

Adenocarcinoma Clinical Trial

— MRP  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00918853
• Other study ID #: MRP/IPC 2007-005
• Secondary ID: ID-RCB 2007-A013
• Status: Completed
• Phase: N/A
• First received: June 9, 2009
• Last updated: March 19, 2015
• Start date: August 2008
• Est. completion date: May 2012

Study information

• Verified date: March 2013
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreas

Intervention

Procedure:
• resection of adenocarcinoma of the head of the pancreas
quality standard for the resection of adenocarcinoma of the head of the pancreas

Locations

Country	Name	City	State
France	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	Creteil
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

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prognostic value of the invasion of the margins measured in millimetres on the overall survival		4 years	No
Secondary	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	No

External Links

•   OFFICIAL WEB SITE OF THE SPONSOR