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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 (MRP)

Primary Purpose

Pancreas, Adenocarcinoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
resection of adenocarcinoma of the head of the pancreas
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreas focused on measuring pancreas, adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu D'Angers
  • Chu de Bordeaux
  • Hopital Ambroise Pare
  • Chu de Clermont-Ferrand
  • Hopital Beaujon
  • Hopital Henri Mondor
  • Hopital de L'Antiquaille
  • Hopital de La Croix-Rousse
  • Hospices Civils de Lyon
  • Chu La Conception
  • Institut Paoli-Calmettes
  • Centre Val D'Aurelle Paul Lamarque
  • Hotel Dieu
  • Hopital Cochin
  • Hopital Pitie-Salpetriere
  • Hopital Tenon
  • Hopitial Saint Antoine
  • Hopital Pontchaillou
  • Hopitaux Universitaires de Strasbourg
  • Chu Purpan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

resection for adenocarcinoma

Arm Description

quality standard resection for adenocarcinoma of the head of the pancreas

Outcomes

Primary Outcome Measures

Prognostic value of the invasion of the margins measured in millimetres on the overall survival

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

Full Information

First Posted
June 9, 2009
Last Updated
March 19, 2015
Sponsor
Institut Paoli-Calmettes
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1. Study Identification

Unique Protocol Identification Number
NCT00918853
Brief Title
Prospective Evaluation of the Resection Margins and the Ganglionic Status Using a Quality Standard Resection for Adenocarcinoma of the Head of the Pancreas
Acronym
MRP
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas, Adenocarcinoma
Keywords
pancreas, adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
resection for adenocarcinoma
Arm Type
Experimental
Arm Description
quality standard resection for adenocarcinoma of the head of the pancreas
Intervention Type
Procedure
Intervention Name(s)
resection of adenocarcinoma of the head of the pancreas
Intervention Description
quality standard for the resection of adenocarcinoma of the head of the pancreas
Primary Outcome Measure Information:
Title
Prognostic value of the invasion of the margins measured in millimetres on the overall survival
Time Frame
4 years
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Robert DELPERO, PhD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu D'Angers
City
Angers
Country
France
Facility Name
Chu de Bordeaux
City
Bordeaux
Country
France
Facility Name
Hopital Ambroise Pare
City
Boulogne
Country
France
Facility Name
Chu de Clermont-Ferrand
City
Clermont-ferrand
Country
France
Facility Name
Hopital Beaujon
City
Clichy
Country
France
Facility Name
Hopital Henri Mondor
City
Creteil
Country
France
Facility Name
Hopital de L'Antiquaille
City
Lyon
Country
France
Facility Name
Hopital de La Croix-Rousse
City
Lyon
Country
France
Facility Name
Hospices Civils de Lyon
City
Lyon
Country
France
Facility Name
Chu La Conception
City
Marseille
Country
France
Facility Name
Institut Paoli-Calmettes
City
Marseille
Country
France
Facility Name
Centre Val D'Aurelle Paul Lamarque
City
Montpellier
Country
France
Facility Name
Hotel Dieu
City
Nantes
Country
France
Facility Name
Hopital Cochin
City
Paris
Country
France
Facility Name
Hopital Pitie-Salpetriere
City
Paris
Country
France
Facility Name
Hopital Tenon
City
Paris
Country
France
Facility Name
Hopitial Saint Antoine
City
Paris
Country
France
Facility Name
Hopital Pontchaillou
City
Rennes
Country
France
Facility Name
Hopitaux Universitaires de Strasbourg
City
Strasbourg
Country
France
Facility Name
Chu Purpan
City
Toulouse
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28953554
Citation
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.
Results Reference
derived
PubMed Identifier
23464850
Citation
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.
Results Reference
derived
Links:
URL
http://www.institutpaolicalmettes.fr/
Description
OFFICIAL WEB SITE OF THE SPONSOR

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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

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