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

Institut Paoli-Calmettes

Status: Completed

Conditions: Pancreas; Adenocarcinoma

Treatments: Procedure: resection of adenocarcinoma of the head of the pancreas

Study type: Interventional

Funder types: Other

Identifiers

NCT00918853

MRP/IPC 2007-005

ID-RCB 2007-A01326-47

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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156 participants in 1 patient group

resection for adenocarcinoma

Experimental group

Description:

quality standard resection for adenocarcinoma of the head of the pancreas

Treatment:

Procedure: resection of adenocarcinoma of the head of the pancreas