The Prognostic Impact of Extracapsular Lymph Node Involvement in Ductal Pancreatic Adenocarcinoma (ECLNI DPAC)
|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.|
|ClinicalTrials.gov Identifier: NCT00644254|
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : July 7, 2009
|Condition or disease||Intervention/treatment|
|Pancreatic Neoplasms Pancreatic Adenocarcinoma||Procedure: Pancreatic resection|
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)
|Study Type :||Observational|
|Actual Enrollment :||145 participants|
|Official Title:||The Prognostic Impact of Extracapsular Lymph Node Involvement (ECLNI) in Ductal Pancreatic Adenocarcinoma (DPAC).|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||March 2008|
145 consecutive resections for primary ductal pancreatic adenocarcinoma (DPAC)performed between 1998 and 2005.
Procedure: Pancreatic resection
PPPD, Whipple, Total pancreatectomy or left pancreatectomy.
- Overall cancer-specific survival [ Time Frame: 11/2007 ]
- Disease-free survival (DFS)& Correlation of ECLNI with other pathological variables [ Time Frame: 11/2007 ]
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
|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|