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

Institut Paoli-Calmettes156 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

156

Conditions

Pancreas Adenocarcinoma

Interventions

resection of adenocarcinoma of the head of the pancreasPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

Chu D'Angers

Angers, France

Chu de Bordeaux

Bordeaux, France

Hopital Ambroise Pare

Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.