NCT00644254

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
Last Updated

July 7, 2009

Status Verified

July 1, 2009

Enrollment Period

1 month

First QC Date

March 20, 2008

Last Update Submit

July 6, 2009

Conditions

Pancreatic NeoplasmsPancreatic Adenocarcinoma

Keywords

PrognosisExtracapsular lymph node involvement

Outcome Measures

Primary Outcomes (1)

  • Overall cancer-specific survival

    11/2007

Secondary Outcomes (1)

  • Disease-free survival (DFS)& Correlation of ECLNI with other pathological variables

    11/2007

Study Arms (1)

Resected DPAC

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

Procedure: Pancreatic resection

Interventions

Pancreatic resectionPROCEDURE

PPPD, Whipple, Total pancreatectomy or left pancreatectomy.

Resected DPAC

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Resected ductal pancreatic adenocarcinoma

You may qualify if:

  • DPAC
  • Primary resection

You may not qualify if:

  • Positive section margins
  • non DPAC, other tumor
  • Postoperative mortality
  • Neoadjuvant chemo/radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Abdominal Surgery

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Baki Topal, MD, PhD

    Catholic University Leuven (KULeuven), Belgium

    STUDY DIRECTOR

  • Gregory Sergeant, MD

    Catholic University Leuven, Belgium

    PRINCIPAL INVESTIGATOR

  • Nadine Ectors, MD, PhD

    Catholic University Leuven, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 20, 2008

First Posted

March 26, 2008

Study Start

October 1, 2007

Primary Completion

November 1, 2007

Study Completion

March 1, 2008

Last Updated

July 7, 2009

Record last verified: 2009-07

Locations

BE(1)