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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00644254
Acronym
ECLNI DPAC
Enrollment
145
Registered
2008-03-26
Start date
2007-10-31
Completion date
2008-03-31
Last updated
2009-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Adenocarcinoma, Pancreatic Neoplasms

Keywords

Prognosis, Extracapsular lymph node involvement

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)

Interventions

PPPD, Whipple, Total pancreatectomy or left pancreatectomy.

Sponsors

Agentschap voor Innovatie door Wetenschap en Technologie
CollaboratorOTHER
KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* DPAC * Primary resection

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Overall cancer-specific survival11/2007

Secondary

MeasureTime frame
Disease-free survival (DFS)& Correlation of ECLNI with other pathological variables11/2007

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026