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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
History of Changes

June 9, 2009
March 19, 2013
August 2008
May 2012   (final data collection date for primary outcome measure)
Prognostic value of the invasion of the margins measured in millimetres on the overall survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00918853 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Prospective Evaluation of the Resection Margins and the Ganglionic Status Using a Quality Standard Resection for Adenocarcinoma of the Head of the Pancreas
Prospective Evaluation of the Resection Margins and the Ganglionic Status Using a Quality Standard Resection for Adenocarcinoma of the Head of the Pancreas.

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.

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.
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pancreas
  • Adenocarcinoma
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
Experimental: resection for adenocarcinoma
quality standard resection for adenocarcinoma of the head of the pancreas
Intervention: Procedure: resection of adenocarcinoma of the head of the pancreas
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
156
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00918853
MRP/IPC 2007-005, ID-RCB 2007-A01326-47
No
Institut Paoli-Calmettes
Institut Paoli-Calmettes
Not Provided
Principal Investigator: Jean Robert DELPERO, PhD Institut Paoli-Calmettes
Institut Paoli-Calmettes
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP