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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00644254
First Posted: March 26, 2008
Last Update Posted: July 7, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Agentschap voor Innovatie door Wetenschap en Technologie
Information provided by:
Katholieke Universiteit Leuven
  Purpose
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.

Condition Intervention
Pancreatic Neoplasms Pancreatic Adenocarcinoma Procedure: Pancreatic resection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Prognostic Impact of Extracapsular Lymph Node Involvement (ECLNI) in Ductal Pancreatic Adenocarcinoma (DPAC).

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Overall cancer-specific survival [ Time Frame: 11/2007 ]

Secondary Outcome Measures:
  • Disease-free survival (DFS)& Correlation of ECLNI with other pathological variables [ Time Frame: 11/2007 ]

Enrollment: 145
Study Start Date: October 2007
Study Completion Date: March 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Resected DPAC
145 consecutive resections for primary ductal pancreatic adenocarcinoma (DPAC)performed between 1998 and 2005.
Procedure: Pancreatic resection
PPPD, Whipple, Total pancreatectomy or left pancreatectomy.

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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Resected ductal pancreatic adenocarcinoma
Criteria

Inclusion Criteria:

  • DPAC
  • Primary resection

Exclusion Criteria:

  • Positive section margins
  • non DPAC, other tumor
  • Postoperative mortality
  • Neoadjuvant chemo/radiotherapy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644254


Locations
Belgium
Department of Abdominal Surgery
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
Agentschap voor Innovatie door Wetenschap en Technologie
Investigators
Study Director: Baki Topal, MD, PhD Catholic University Leuven (KULeuven), Belgium
Principal Investigator: Gregory Sergeant, MD Catholic University Leuven, Belgium
Principal Investigator: Nadine Ectors, MD, PhD Catholic University Leuven, Belgium
  More Information

ClinicalTrials.gov Identifier: NCT00644254     History of Changes
Other Study ID Numbers: ECLNI DPAC
First Submitted: March 20, 2008
First Posted: March 26, 2008
Last Update Posted: July 7, 2009
Last Verified: July 2009

Keywords provided by Katholieke Universiteit Leuven:
Prognosis
Extracapsular lymph node involvement

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases