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

Overview

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.

Full Title of Study: “Prospective Evaluation of the Resection Margins and the Ganglionic Status Using a Quality Standard Resection for Adenocarcinoma of the Head of the Pancreas.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2012

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.

Interventions

  • 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

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

Clinical Trial Outcome Measures

Primary Measures

  • Prognostic value of the invasion of the margins measured in millimetres on the overall survival
    • Time Frame: 4 years

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

Participating 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: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • 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

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