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NCT01959906 Clinical Trial

Circumferential Section Pane Less Than 1 mm in Esophagectomy for Esophageal Cancer.

Esophageal Cancer Clinical Trial

Official title:
Prognostic Value of a Circumferential Section Pane Less Than 1 mm in Esophagectomy for Esophageal Cancer.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01959906
Other study ID # CRM<1mm
Secondary ID
Status Active, not recruiting
Phase N/A
First received October 8, 2013
Last updated October 9, 2013
Start date July 2013
Est. completion date June 2014

Study information
Verified date October 2013
Source University Hospital, Gasthuisberg
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicines and Health Products, FAMHP
Study type Observational

Clinical Trial Summary

A suspicious circumferential resection margin (CRM), defined as tumor cells within 1 mm of the CRM, is still controversial. The aim of this study was to compare the clinical significance of a suspicious CRM to histologically positive (R1) and negative margin (R0) resections in patients with pT3 esophageal and GE-Junction tumors.

Description:

From our prospectively build database 923 consecutive pT3 patients operated between january 1990 and june 2013 were selected. CRM status in patients treated by surgery only (n = 747) or after neoadjuvant therapy (n = 176) was recorded prospectively after surgery.

Kaplan-Meier survival curves were generated, and factors affecting survival were assessed by Cox regression multivariate analysis.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 923
Est. completion date June 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 95 Years
Eligibility Inclusion Criteria:

- pathologic T3 tumours of esophagus or GEJ

Exclusion Criteria:

- pT other than pT3

- R2 resections

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium University Hospital Leuven Leuven

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Gasthuisberg

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary overall survival 5 years overall survival after esophagectomy 5 years after esophagectomy No
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