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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


2008-08


2012-05


2012-05


156

Study Overview

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.

  • Pancreas
  • Adenocarcinoma
  • PROCEDURE: resection of adenocarcinoma of the head of the pancreas
  • MRP/IPC 2007-005
  • ID-RCB 2007-A01326-47

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 Registration Dates Results Reporting Dates Study Record Updates

2009-06-09  

N/A  

2015-03-19  

2009-06-10  

N/A  

2015-03-20  

2009-06-11  

N/A  

2013-03  

Study Plan

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

Design Details

Primary Purpose:
Treatment


Allocation:
Na


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/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
Primary Outcome MeasuresMeasure DescriptionTime Frame
Prognostic value of the invasion of the margins measured in millimetres on the overall survival4 years
Secondary Outcome MeasuresMeasure DescriptionTime 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 relapse4 years

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

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


    • PRINCIPAL_INVESTIGATOR: Jean Robert DELPERO, PhD, Institut Paoli-Calmettes

    Publications

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

    General Publications

    • Delpero JR, Jeune F, Bachellier P, Regenet N, Le Treut YP, Paye F, Carrere N, Sauvanet A, Adham M, Autret A, Poizat F, Turrini O, Boher JM. Prognostic Value of Resection Margin Involvement After Pancreaticoduodenectomy for Ductal Adenocarcinoma: Updates From a French Prospective Multicenter Study. Ann Surg. 2017 Nov;266(5):787-796. doi: 10.1097/SLA.0000000000002432.
    • Delpero JR, Bachellier P, Regenet N, Le Treut YP, Paye F, Carrere N, Sauvanet A, Autret A, Turrini O, Monges-Ranchin G, Boher JM. Pancreaticoduodenectomy for pancreatic ductal adenocarcinoma: a French multicentre prospective evaluation of resection margins in 150 evaluable specimens. HPB (Oxford). 2014 Jan;16(1):20-33. doi: 10.1111/hpb.12061. Epub 2013 Mar 7.