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

NCT ID: NCT00918853

Last Updated: 2015-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-05-31

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.

Conditions

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Pancreas Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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resection for adenocarcinoma

quality standard resection for adenocarcinoma of the head of the pancreas

Group Type EXPERIMENTAL

resection of adenocarcinoma of the head of the pancreas

Intervention Type PROCEDURE

quality standard for the resection of adenocarcinoma of the head of the pancreas

Interventions

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resection of adenocarcinoma of the head of the pancreas

quality standard for the resection of adenocarcinoma of the head of the pancreas

Intervention Type PROCEDURE

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


* pregnancy, breast feeding
* patient in an urgency situation or patient with legal protection

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Paoli-Calmettes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Robert DELPERO, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes

Locations

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Chu D'Angers

Angers, , France

Site Status

Chu de Bordeaux

Bordeaux, , France

Site Status

Hopital Ambroise Pare

Boulogne, , France

Site Status

Chu de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Hopital Beaujon

Clichy, , France

Site Status

Hopital Henri Mondor

Créteil, , France

Site Status

Hopital de L'Antiquaille

Lyon, , France

Site Status

Hopital de La Croix-Rousse

Lyon, , France

Site Status

Hospices Civils de Lyon

Lyon, , France

Site Status

Chu La Conception

Marseille, , France

Site Status

Institut Paoli-Calmettes

Marseille, , France

Site Status

Centre Val D'Aurelle Paul Lamarque

Montpellier, , France

Site Status

Hotel Dieu

Nantes, , France

Site Status

Hopital Cochin

Paris, , France

Site Status

Hopital Pitie-Salpetriere

Paris, , France

Site Status

Hopital Tenon

Paris, , France

Site Status

Hopitial Saint Antoine

Paris, , France

Site Status

Hopital Pontchaillou

Rennes, , France

Site Status

Hopitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status

Chu Purpan

Toulouse, , France

Site Status

Countries

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France

References

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Delpero JR, Jeune F, Bachellier P, Regenet N, Le Treut YP, Paye F, Carrere N, Sauvanet A, Adham M, Autret A, Poizat F, Turrini O, Boher JM. Prognostic Value of Resection Margin Involvement After Pancreaticoduodenectomy for Ductal Adenocarcinoma: Updates From a French Prospective Multicenter Study. Ann Surg. 2017 Nov;266(5):787-796. doi: 10.1097/SLA.0000000000002432.

Reference Type DERIVED
PMID: 28953554 (View on PubMed)

Delpero JR, Bachellier P, Regenet N, Le Treut YP, Paye F, Carrere N, Sauvanet A, Autret A, Turrini O, Monges-Ranchin G, Boher JM. Pancreaticoduodenectomy for pancreatic ductal adenocarcinoma: a French multicentre prospective evaluation of resection margins in 150 evaluable specimens. HPB (Oxford). 2014 Jan;16(1):20-33. doi: 10.1111/hpb.12061. Epub 2013 Mar 7.

Reference Type DERIVED
PMID: 23464850 (View on PubMed)

Related Links

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http://www.institutpaolicalmettes.fr/

OFFICIAL WEB SITE OF THE SPONSOR

Other Identifiers

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ID-RCB 2007-A01326-47

Identifier Type: -

Identifier Source: secondary_id

MRP/IPC 2007-005

Identifier Type: -

Identifier Source: org_study_id

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