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

March 19, 2015 updated by: Institut Paoli-Calmettes

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • CHU d'Angers
      • Bordeaux, France
        • CHU de Bordeaux
      • Boulogne, France
        • Hôpital Ambroise Paré
      • Clermont-ferrand, France
        • CHU de Clermont-Ferrand
      • Clichy, France
        • Hopital Beaujon
      • Creteil, France
        • Hôpital Henri Mondor
      • Lyon, France
        • Hospices Civils de LYON
      • Lyon, France
        • Hôpital de la Croix-Rousse
      • Lyon, France
        • Hopital de L'Antiquaille
      • Marseille, France
        • Institut Paoli-Calmettes
      • Marseille, France
        • CHU la Conception
      • Montpellier, France
        • Centre Val d'Aurelle Paul Lamarque
      • Nantes, France
        • Hotel Dieu
      • Paris, France
        • Hôpital Pitié-Salpêtrière
      • Paris, France
        • Hôpital Cochin
      • Paris, France
        • Hopital Tenon
      • Paris, France
        • Hopitial Saint Antoine
      • Rennes, France
        • Hopital Pontchaillou
      • Strasbourg, France
        • Hôpitaux Universitaires de Strasbourg
      • Toulouse, France
        • CHU Purpan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Investigators

  • Principal Investigator: Jean Robert DELPERO, PhD, Institut Paoli-Calmettes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

June 9, 2009

First Submitted That Met QC Criteria

June 10, 2009

First Posted (Estimate)

June 11, 2009

Study Record Updates

Last Update Posted (Estimate)

March 20, 2015

Last Update Submitted That Met QC Criteria

March 19, 2015

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRP/IPC 2007-005
  • ID-RCB 2007-A01326-47

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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