Pancreatic NeoplasmsECLNI DPACNCT00644254
The Prognostic Impact of Extracapsular Lymph Node Involvement in Ductal Pancreatic Adenocarcinoma
An observational study of Pancreatic Neoplasms and Pancreatic Adenocarcinoma, run by KU Leuven at 1 site in Belgium.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Neoplasms, Pancreatic Adenocarcinoma
- What is being tested?
- Pancreatic resection
- Type of treatment
- Surgery or procedure
- How many people
- 145 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2007to Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Resected ductal pancreatic adenocarcinoma
Who may be able to join
- DPAC
- Primary resection
Who cannot join
- Positive section margins
- non DPAC, other tumor
- Postoperative mortality
- Neoadjuvant chemo/radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prognostic Impact of Extracapsular Lymph Node Involvement (ECLNI) in Ductal Pancreatic Adenocarcinoma (DPAC).
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.
Read the 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)
- Conditions
- Pancreatic Neoplasms, Pancreatic Adenocarcinoma
- Being tested
- Pancreatic resection
- Keywords
- Prognosis, Extracapsular lymph node involvement
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic resectionProcedure or surgery
PPPD, Whipple, Total pancreatectomy or left pancreatectomy.
| Study group | Role | What they receive |
|---|---|---|
| Resected DPAC | 145 consecutive resections for primary ductal pancreatic adenocarcinoma (DPAC)performed between 1998 and 2005. Receives: Procedure: Pancreatic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall cancer-specific survival
Measured: 11/2007
Secondary outcomes (1)
Disease-free survival (DFS)& Correlation of ECLNI with other pathological variables
Measured: 11/2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startOct 2007
- Primary completionNov 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie
- Investigators
- Baki Topal, MD, PhD, Study director, Catholic University Leuven (KULeuven), BelgiumGregory Sergeant, MD, Principal investigator, Catholic University Leuven, BelgiumNadine Ectors, MD, PhD, Principal investigator, Catholic University Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644254
- Sponsor's protocol ID
- ECLNI DPAC
- Acronym
- ECLNI DPAC
- Status last verified
- Jul 2009
- First submitted
- 20 Mar 2008
- Last updated
- 7 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Impact of Extracapsular Lymph Node Involvement (ECLNI) in Ductal Pancreatic Adenocarcinoma (DPAC).
- ClinicalTrials.gov ID
- NCT00644254
- Acronym / sponsor ID
- ECLNI DPAC / ECLNI DPAC
- Conditions
- Pancreatic Neoplasms, Pancreatic Adenocarcinoma
- Keywords
- Prognosis, Extracapsular lymph node involvement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie
- Study start
- Oct 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 26 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resected DPAC | – | Procedure: Pancreatic resection145 consecutive resections for primary ductal pancreatic adenocarcinoma (DPAC)performed between 1998 and 2005. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Resected ductal pancreatic adenocarcinoma
Key inclusion criteria (2 listed)
- DPAC
- Primary resection
Key exclusion criteria (4 listed)
- Positive section margins
- non DPAC, other tumor
- Postoperative mortality
- Neoadjuvant chemo/radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pancreatic resectionPPPD, Whipple, Total pancreatectomy or left pancreatectomy. | Procedure or surgery | Resected DPAC |
Primary outcome
Overall cancer-specific survival
Time frame: 11/2007
1 secondary outcome
Disease-free survival (DFS)& Correlation of ECLNI with other pathological variables
Time frame: 11/2007
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baki Topal, MD, PhD study director
Catholic University Leuven (KULeuven), Belgium
Gregory Sergeant, MD principal investigator
Catholic University Leuven, Belgium
Nadine Ectors, MD, PhD principal investigator
Catholic University Leuven, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neoplasms and Pancreatic Adenocarcinoma, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall cancer-specific survival (time frame: 11/2007). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2009.