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

• Sponsor: KU Leuven (Other)
• Overall Status: Completed
• CT.gov ID: NCT00644254
• Collaborator: Agentschap voor Innovatie door Wetenschap en Technologie (Other)
• Enrollment: 145
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 29

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Pancreatic Neoplasms; Pancreatic Adenocarcinoma	Procedure: Pancreatic resection

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)

Study Design

• Study Type: Observational
• Actual Enrollment: 145 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: The Prognostic Impact of Extracapsular Lymph Node Involvement (ECLNI) in Ductal Pancreatic Adenocarcinoma (DPAC).
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Nov 1, 2007
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Overall cancer-specific survival [11/2007]

Secondary Outcome Measures

1. Disease-free survival (DFS)& Correlation of ECLNI with other pathological variables [11/2007]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• DPAC

• Primary resection

Exclusion Criteria:

• Positive section margins

• non DPAC, other tumor

• Postoperative mortality

• Neoadjuvant chemo/radiotherapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Abdominal Surgery	Leuven	Vlaams-Brabant	Belgium	3000

Sponsors and Collaborators

• KU 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00644254
• Other Study ID Numbers: ECLNI DPAC
• First Posted: Mar 26, 2008
• Last Update Posted: Jul 7, 2009
• Last Verified: Jul 1, 2009

• Keywords provided by , ,: Prognosis; Extracapsular lymph node involvement
• Additional relevant MeSH terms: Adenocarcinoma; Pancreatic Neoplasms

Study Results

No Results Posted as of Jul 7, 2009