Prospective Evaluation of the Resection Margins and the Ganglionic Status Using a Quality Standard Resection for Adenocarcinoma of the Head of the Pancreas (MRP)
This study has been completed.
Sponsor:
Institut Paoli-Calmettes
Information provided by (Responsible Party):
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT00918853
First received: June 9, 2009
Last updated: March 19, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pancreas Adenocarcinoma |
Procedure: resection of adenocarcinoma of the head of the pancreas |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prospective Evaluation of the Resection Margins and the Ganglionic Status Using a Quality Standard Resection for Adenocarcinoma of the Head of the Pancreas. |
Resource links provided by NLM:
Further study details as provided by Institut Paoli-Calmettes:
Primary Outcome Measures:
- Prognostic value of the invasion of the margins measured in millimetres on the overall survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 [ Time Frame: 4 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 156 |
| Study Start Date: | August 2008 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Other Name: 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918853
Locations
| France | |
| 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 | |
| Institut Paoli-Calmettes | |
| Marseille, France | |
| Chu La Conception | |
| Marseille, France | |
| Centre Val D'Aurelle Paul Lamarque | |
| Montpellier, France | |
| Hotel Dieu | |
| Nantes, France | |
| Hopital Cochin | |
| Paris, France | |
| Hopital Pitie-Salpetriere | |
| Paris, France | |
| Hopitial Saint Antoine | |
| Paris, France | |
| Hopital Tenon | |
| Paris, France | |
| Hopital Pontchaillou | |
| Rennes, France | |
| Hopitaux Universitaires de Strasbourg | |
| Strasbourg, France | |
| Chu Purpan | |
| Toulouse, France | |
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
| Principal Investigator: | Jean Robert DELPERO, PhD | Institut Paoli-Calmettes |
More Information
Additional Information:
No publications provided
| Responsible Party: | Institut Paoli-Calmettes |
| ClinicalTrials.gov Identifier: | NCT00918853 History of Changes |
| Other Study ID Numbers: | MRP/IPC 2007-005, ID-RCB 2007-A01326-47 |
| Study First Received: | June 9, 2009 |
| Last Updated: | March 19, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Institut Paoli-Calmettes:
|
pancreas adenocarcinoma |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Cystic, Mucinous, and Serous Pancreatin Pancrelipase Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013