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

Pancreatic Neoplasms Clinical Trial

— ECLNI DPAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644254
• Other study ID #: ECLNI DPAC
• Status: Completed
• Phase: N/A
• First received: March 20, 2008
• Last updated: July 6, 2009
• Start date: October 2007
• Est. completion date: March 2008

Study information

• Verified date: July 2009
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: March 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• DPAC

• Primary resection

Exclusion Criteria:

• Positive section margins

• non DPAC, other tumor

• Postoperative mortality

• Neoadjuvant chemo/radiotherapy

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma
• Pancreatic Neoplasms

Intervention

Procedure:
• Pancreatic resection
PPPD, Whipple, Total pancreatectomy or left pancreatectomy.

Locations

Country	Name	City	State
Belgium	Department of Abdominal Surgery	Leuven	Vlaams-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven	Agentschap voor Innovatie door Wetenschap en Technologie

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall cancer-specific survival		11/2007	No
Secondary	Disease-free survival (DFS)& Correlation of ECLNI with other pathological variables		11/2007	No