The Prognostic Impact of Extracapsular Lymph Node Involvement in Ductal Pancreatic Adenocarcinoma (ECLNI DPAC)
|Pancreatic Neoplasms Pancreatic Adenocarcinoma||Procedure: Pancreatic resection|
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||The Prognostic Impact of Extracapsular Lymph Node Involvement (ECLNI) in Ductal Pancreatic Adenocarcinoma (DPAC).|
- Overall cancer-specific survival [ Time Frame: 11/2007 ]
- Disease-free survival (DFS)& Correlation of ECLNI with other pathological variables [ Time Frame: 11/2007 ]
|Study Start Date:||October 2007|
|Study Completion Date:||March 2008|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
145 consecutive resections for primary ductal pancreatic adenocarcinoma (DPAC)performed between 1998 and 2005.
Procedure: Pancreatic resection
PPPD, Whipple, Total pancreatectomy or left pancreatectomy.
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.
- Common closing date: 1/11/2007
- Kaplan-Meier survival analysis (Log-Rank, Wilcoxon)
- Cox logistic regression (uni/multivariate)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644254
|Department of Abdominal Surgery|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|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|