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

NCT ID: NCT00644254

Last Updated: 2009-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

145 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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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)

Conditions

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Pancreatic Neoplasms Pancreatic Adenocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Resected DPAC

145 consecutive resections for primary ductal pancreatic adenocarcinoma (DPAC)performed between 1998 and 2005.

Pancreatic resection

Intervention Type PROCEDURE

PPPD, Whipple, Total pancreatectomy or left pancreatectomy.

Interventions

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Pancreatic resection

PPPD, Whipple, Total pancreatectomy or left pancreatectomy.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* DPAC
* Primary resection

Exclusion Criteria

* Positive section margins
* non DPAC, other tumor
* Postoperative mortality
* Neoadjuvant chemo/radiotherapy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agentschap voor Innovatie door Wetenschap en Technologie

OTHER

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role lead

Principal Investigators

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Baki Topal, MD, PhD

Role: STUDY_DIRECTOR

Catholic University Leuven (KULeuven), Belgium

Gregory Sergeant, MD

Role: PRINCIPAL_INVESTIGATOR

Catholic University Leuven, Belgium

Nadine Ectors, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Catholic University Leuven, Belgium

Locations

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Department of Abdominal Surgery

Leuven, Vlaams-Brabant, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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ECLNI DPAC

Identifier Type: -

Identifier Source: org_study_id

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