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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Pancreas, Adenocarcinoma

Intervention / Treatment
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* Procedure: resection of adenocarcinoma of the head of the pancreas


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: resection for adenocarcinoma<br>quality standard resection for adenocarcinoma of the head of the pancreas | Procedure: resection of adenocarcinoma of the head of the pancreas<br>* quality standard for the resection of adenocarcinoma of the head of the pancreas<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreas, adenocarcinoma