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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.


N/A
18 Years
N/A
Not Enrolling
Both
Pancreas, Adenocarcinoma

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Trial Information

Prospective Evaluation of the Resection Margins and the Ganglionic Status Using a Quality Standard Resection for 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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Prognostic value of the invasion of the margins measured in millimetres on the overall survival

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

Jean Robert DELPERO, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Paoli-Calmettes

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

MRP/IPC 2007-005

NCT ID:

NCT00918853

Start Date:

August 2008

Completion Date:

May 2012

Related Keywords:

  • Pancreas
  • Adenocarcinoma
  • pancreas
  • adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous

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