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Completed

NCT Number: NCT00644254

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

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.

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Key information

Conditions

Pancreatic Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Adenocarcinoma Pancreatic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Abdominal Surgery

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • DPAC
  • Primary resection

Exclusion criteria

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

Treatment and study plan

Pancreatic resection

Procedure

PPPD, Whipple, Total pancreatectomy or left pancreatectomy.

Primary outcomes

  1. Overall cancer-specific survival

    Time frame: 11/2007

Secondary outcomes

  1. Disease-free survival (DFS)& Correlation of ECLNI with other pathological variables

    Time frame: 11/2007

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Agentschap voor Innovatie door Wetenschap en Technologie

Registry information

Official study title

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

Acronym: ECLNI DPAC

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Mar 26, 2008
Registry last updated
Jul 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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