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

NCT ID: NCT01959906

Last Updated: 2013-10-10

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

UNKNOWN

Total Enrollment

923 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Esophageal Cancer

Keywords

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Esophagectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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R0

Complete resection

No interventions assigned to this group

R1

Incomplete resection, microscopical tumor residu left behind

No interventions assigned to this group

CRM<1mm

complete resection (R0), however tumor spreads till less than 1 mm from the section pane.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* pathologic T3 tumours of esophagus or GEJ

Exclusion Criteria

* pT other than pT3
* R2 resections
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Gasthuisberg

OTHER

Sponsor Role lead

Responsible Party

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Johnny Moons

Datameanager Thoracic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philippe Nafteux, MD

Role: STUDY_DIRECTOR

University Hospital Leuven, dept. Thoracic Surgery

Katrien Van de Steen, MSc

Role: PRINCIPAL_INVESTIGATOR

Katholic University Leuven

Locations

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University Hospital Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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CRM<1mm

Identifier Type: -

Identifier Source: org_study_id