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

This study has been completed.
Sponsor:
Collaborator:
Agentschap voor Innovatie door Wetenschap en Technologie
Information provided by:
Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT00644254
First received: March 20, 2008
Last updated: July 6, 2009
Last verified: July 2009
History of Changes
  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).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Overall cancer-specific survival [ Time Frame: 11/2007 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-free survival (DFS)& Correlation of ECLNI with other pathological variables [ Time Frame: 11/2007 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00644254     History of Changes
Other Study ID Numbers: ECLNI DPAC
Study First Received: March 20, 2008
Last Updated: July 6, 2009
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

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

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

ClinicalTrials.gov processed this record on May 19, 2013