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

Not Applicable

Completed

• Conditions: Adenocarcinoma; Pancreas

• Registration Number: NCT00918853
• Lead Sponsor: Institut Paoli-Calmettes

Brief Summary

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

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 Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-06-09
• Study First Submitted QC: 2009-06-10
• Study First Posted: 2009-06-11
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-03
• Last Update Submitted: 2015-03-19
• Last Update Posted: 2015-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Prognostic value of the invasion of the margins measured in millimetres on the overall survival	4 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (20)

Chu D'Angers; 🇫🇷 Angers, France

Chu de Bordeaux; 🇫🇷 Bordeaux, France

Hopital Ambroise Pare; 🇫🇷 Boulogne, France

Chu de Clermont-Ferrand; 🇫🇷 Clermont-ferrand, France

Hopital Beaujon; 🇫🇷 Clichy, France

Hopital Henri Mondor; 🇫🇷 Creteil, France

Hopital de L'Antiquaille; 🇫🇷 Lyon, France

Hopital de La Croix-Rousse; 🇫🇷 Lyon, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France

Chu La Conception; 🇫🇷 Marseille, France

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