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

Brief Summary

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.”

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.

  • Study Type: Interventional
  • Study Design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: May 2012

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

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

Outcome Measures for this Clinical Trial

Primary Measures

  • Prognostic value of the invasion of the margins measured in millimetres on the overall survival
    • Time Frame: 4 years
      Safety Issue?: No

Secondary 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
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Institut Paoli-Calmettes
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jean Robert DELPERO, PhD, Principal Investigator, Institut Paoli-Calmettes

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00918853