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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pancreas Adenocarcinoma Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu D'Angers, Angers, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

resection of adenocarcinoma of the head of the pancreas

Procedure

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

Primary outcomes

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

Time frame: 4 years

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study 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

Important dates

Study start: 2008
Primary completion: 2012
Study completion: 2012
First posted: Jun 11, 2009
Registry last updated: Mar 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed