The Prognostic Impact of Extracapsular Lymph Node Involvement in Ductal Pancreatic Adenocarcinoma (ECLNI DPAC)

Catholic University (KU) of Leuven

Status: Completed

Conditions: Pancreatic Adenocarcinoma; Pancreatic Neoplasms

Treatments: Procedure: Pancreatic resection

Study type: Observational

Funder types: Other

Identifiers

NCT00644254

ECLNI DPAC

Details and patient eligibility

About

Extracapsular lymph node involvement (ECLNI) has been identified as a pathological variable associated with worse outcome in esophageal, gastric and colorectal cancer. No studies so far have studied its prognostic impact in ductal pancreatic adenocarcinoma (DPAC). The goal of the investigators is to determine the prognostic value of ECLNI in a prospective consecutive series of 145 patients with DPAC, who underwent resection of their primary tumor between 1998 and 2005.

Full description

Presence and extent of extracapsular lymph node involvement (ECLNI) will be scored by reviewing all original pathological slides.

ECLNI is defined as metastatic adenocarcinoma extending through the nodal capsule into the perinodal fatty tissue.

Observers: 1 experienced board-certified GI pathologist, blinded for follow-up results.

Follow-up data are obtained by reviewing patients charts and by a telephone survey of the patient's GP/gastroenterologist in November 2007.

Statistical analysis:

• Common closing date: 1/11/2007
• Kaplan-Meier survival analysis (Log-Rank, Wilcoxon)
• Cox logistic regression (uni/multivariate)

Enrollment: 145 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• DPAC
• Primary resection

Exclusion criteria

• Positive section margins
• non DPAC, other tumor
• Postoperative mortality
• Neoadjuvant chemo/radiotherapy

Trial design

145 participants in 1 patient group

Resected DPAC

Description:

145 consecutive resections for primary ductal pancreatic adenocarcinoma (DPAC)performed between 1998 and 2005.

Treatment:

Procedure: Pancreatic resection