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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT00918853
First received: June 9, 2009
Last updated: March 19, 2013
Last verified: March 2013
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: resection for adenocarcinoma
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
Other Name: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Institut Paoli-Calmettes
Marseille, France
Chu La Conception
Marseille, France
Centre Val D'Aurelle Paul Lamarque
Montpellier, France
Hotel Dieu
Nantes, France
Hopital Cochin
Paris, France
Hopital Pitie-Salpetriere
Paris, France
Hopitial Saint Antoine
Paris, France
Hopital Tenon
Paris, France
Hopital Pontchaillou
Rennes, France
Hopitaux Universitaires de Strasbourg
Strasbourg, France
Chu Purpan
Toulouse, France
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
Principal Investigator: Jean Robert DELPERO, PhD Institut Paoli-Calmettes
  More Information

Additional Information:
No publications provided by Institut Paoli-Calmettes

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT00918853     History of Changes
Other Study ID Numbers: MRP/IPC 2007-005, ID-RCB 2007-A01326-47
Study First Received: June 9, 2009
Last Updated: March 19, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Paoli-Calmettes:
pancreas
adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014