Multicentric Retrospective Review of Extracapsular Lymph Node Involvement After Esophagectomy
ECLNI-MC
Can Extracapsular Lymph Node Involvement be a Tool to Fine-tune UICC TNM 7th Edition for Esophageal Carcinoma?
1 other identifier
observational
2,000
1 country
1
Brief Summary
It is well known that lymph node metastasis is one of the most important prognostic factors in oesophageal carcinoma. The investigators want to determine the influence of lymph node characteristics, being either intracapsular or extracapsular, on overall survival after esophagectomy for esophageal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2013
Shorter than P25 for all trials
1 active site
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
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 2, 2013
CompletedFirst Posted
Study publicly available on registry
April 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedApril 23, 2013
April 1, 2013
4 months
April 2, 2013
April 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall survival by LN-status (being ECLNI or ICLNI)
according UICC TNM7 pN (pN1-2-3)
5 yrs from surgery
Cancer-specific survival by LN-status (being ECLNI or ICLNI)
according UICC TNM7 pN (pN1-2-3)- censoring non-esophageal cancer related deaths
5 yrs from surgery
Secondary Outcomes (1)
Cancer specific survival for intra- and extracapsular lymph node involvement
5 yrs from surgery
Other Outcomes (1)
Cancer specific survival for intra- and extracapsular lymph node involvement
5 yrs from surgery
Study Arms (2)
Extracapsular LNI
Patients with positive lymph nodes that show extracapsular lymph node involvement
Intracapsular LNI
Patients with positive lymph nodes that show NO extracapsular lymph node involvement
Eligibility Criteria
Multicentric cohort study, patient chart analysis Since several high volume European institutions have published their results on patients with extracapsular lymph node involvement, we plan a pooling of their 'raw' data regarding type of treatment, histology, extracapsular LNI and (disease-free) survival.
You may qualify if:
- Adequate lymph node sampling is of paramount importance. (pT1 - min. 10 LN; \>pT2 min. 20 LN resected). At least the following lymph node stations should be examined: perioesophageal distal 1/3 and perigastric LN, left gastric artery, splenic artery, common hepatic artery, subcarinal lymph nodes. Sugical technique (transthoracic, transhiatal or minimal invasive) is less important if the criterium of adequate lymph node sampling is fulfilled but should be mentioned.
You may not qualify if:
- unforeseen organ metastasis
- subcardia tumors
- histology other than adenocarcinoma or squamous cell carcinoma
- Postoperative (inhospital or 30-day) mortality
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Leuven, Gasthuisberg
Leuven, 3000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- RN, MSc, Datamanager
Study Record Dates
First Submitted
April 2, 2013
First Posted
April 23, 2013
Study Start
March 1, 2013
Primary Completion
July 1, 2013
Study Completion
November 1, 2013
Last Updated
April 23, 2013
Record last verified: 2013-04