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
• Interventions: Procedure: resection of adenocarcinoma of the head of the 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

Arm && Interventions

Group	Intervention	Description
resection for adenocarcinoma	resection of adenocarcinoma of the head of the pancreas	quality standard resection for adenocarcinoma of the head of the pancreas

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

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

Hopital Ambroise Pare; 🇫🇷 Boulogne, France

Hopital Henri Mondor; 🇫🇷 Creteil, France

Hopital Beaujon; 🇫🇷 Clichy, France

Hopital de L'Antiquaille; 🇫🇷 Lyon, France

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

Chu La Conception; 🇫🇷 Marseille, France

Hopital Pitie-Salpetriere; 🇫🇷 Paris, France

Institut Paoli-Calmettes; 🇫🇷 Marseille, France

Centre Val D'Aurelle Paul Lamarque; 🇫🇷 Montpellier, France

Hotel Dieu; 🇫🇷 Nantes, France

Hopital Tenon; 🇫🇷 Paris, France

Hopitial Saint Antoine; 🇫🇷 Paris, France

Chu Purpan; 🇫🇷 Toulouse, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France

Hopital Pontchaillou; 🇫🇷 Rennes, France

Hopitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

Hopital Cochin; 🇫🇷 Paris, France