The Prognostic Impact of Extracapsular Lymph Node Involvement in Ductal Pancreatic Adenocarcinoma - Full Text View

Sponsors and Collaborators:	Katholieke Universiteit Leuven IWT, Flanders, Belgium
Information provided by:	Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:	NCT00644254

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:	Cohort, Retrospective
Official Title:	The Prognostic Impact of Extracapsular Lymph Node Involvement (ECLNI) in Ductal Pancreatic Adenocarcinoma (DPAC).

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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, Vlaams-Brabant
Department of Abdominal Surgery
Leuven, Vlaams-Brabant, Belgium, 3000

Sponsors and Collaborators

Katholieke Universiteit Leuven

IWT, Flanders, Belgium

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

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

Keywords provided by Katholieke Universiteit Leuven:

Prognosis
Extracapsular lymph node involvement

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms

Endocrinopathy
Adenocarcinoma
Endocrine Gland Neoplasms
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Neoplasms by Histologic Type
Pancreatic Neoplasms

Endocrine System Diseases
Pancreatic Diseases
Adenocarcinoma
Endocrine Gland Neoplasms
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on September 10, 2009