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

Completed

• Conditions: Pancreatic Neoplasms; Pancreatic Adenocarcinoma
• Interventions: Procedure: Pancreatic resection

• Registration Number: NCT00644254
• Lead Sponsor: KU Leuven

Brief 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)

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2007-11
• Study Completion: 2008-03
• Study First Submitted: 2008-03-20
• Study First Submitted QC: 2008-03-20
• Study First Posted: 2008-03-26
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-06
• Last Update Posted: 2009-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

• DPAC
• Primary resection

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Resected DPAC	Pancreatic resection	145 consecutive resections for primary ductal pancreatic adenocarcinoma (DPAC)performed between 1998 and 2005.

Primary Outcome Measures

Name	Time	Method
Overall cancer-specific survival	11/2007

Secondary Outcome Measures

Name	Time	Method
Disease-free survival (DFS)& Correlation of ECLNI with other pathological variables	11/2007

Trial Locations

Locations (1)

Department of Abdominal Surgery; 🇧🇪 Leuven, Vlaams-Brabant, Belgium