Clinical Trials Directory

Trials / Completed

CompletedNCT00644254

The Prognostic Impact of Extracapsular Lymph Node Involvement in Ductal Pancreatic Adenocarcinoma

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

Status
Completed
Phase
Study type
Observational
Enrollment
145 (actual)
Sponsor
KU Leuven · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

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.

Detailed 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)

Conditions

Interventions

TypeNameDescription
PROCEDUREPancreatic resectionPPPD, Whipple, Total pancreatectomy or left pancreatectomy.

Timeline

Start date
2007-10-01
Primary completion
2007-11-01
Completion
2008-03-01
First posted
2008-03-26
Last updated
2009-07-07

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT00644254. Inclusion in this directory is not an endorsement.