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Nodal Upstaging in VATS Anatomical Resections for NSCLC

NCT ID: NCT01985659

Last Updated: 2013-11-15

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

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-06-30

Brief Summary

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This study investigates peropeative nodal upstaging during anatomical resections for non-small-cell-lung-cancer in an era of rising numbers of VATS anatomical resections. In case of comparable study groups, unchanged pretreatment staging and equal quality of pathologic examination, lymph node upstaging is a marker of surgical quality and can be used to study the quality of a new surgical technique.

Detailed Description

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Vats lobectomy is becoming the standard of care for early stage lung cancer. Several studies have shown feasibility and safety in dedicated centres. Compared to thoracotomy the procedure is believed to achieve equal oncologic results and survival, perhaps better.

Publications have shown that mediastianal lymph node dissection during VATS is similar.

However, two recent reports have shown potential lower N1 (hilar and intrapulmonary) upstaging in VATS surgery After optimal staging the percentage of unforeseen N+ the percentage of unforeseen positive nodes can reach 15%

Nodal upstaging at final pathology is dependent on the quality of:

* pretreatment staging, the better, the less upstaging
* surgery, ie mediastinal, hilar and intrapulmonary lymphadenectomy
* pathologic examination If we accept that pretreatment staging and pathologic examination are equal in two comparable surgical cohorts, the finding of unforeseen N+ or nodal upstaging is a quality marker of surgery. When surgical techniques are changing, it is important to look at this marker.

In absence of a randomized trial, we believe a cohort analysis is useful. By including all patients, open or vats, and comparing cohorts instead of the surgical technique used, the selection bias is absent. We compare three cohorts. In the first (20007-2009) almost all patients where operated through a thoracotomy. In a second cohort, (2010-2011) the experience with vats was early. In the third period (2012-2013), a standardized vats technique with extensive intrapulmonary and mediastinal lymphadenectomy was used.

Conditions

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Carcinoma, Non-Small-Cell Lung

Keywords

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Lymph Node Excision Thoracic Surgical Procedures Thoracic Surgery, Video-Assisted Thoracotomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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open thoracotomy

In the first cohort(20007-2009) almost all patients where operated through a thoracotomy.

No interventions assigned to this group

Early VATS

In a second cohort, (2010-2011) the experience with vats was early.

No interventions assigned to this group

Standardized VATS

In the third period (2012-2013), a standardized vats technique with extensive intrapulmonary and mediastinal lymphadenectomy was used.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All cN0, cN1 patients that underwent segmentectomy, lobectomy, sleeve lobectomy for NSCLC.

Exclusion Criteria

* cN2
* cM+
* Pneumonectomy
* Previous lung cancer surgery - lymphadenectomy
* Neo-adjunvant therapy
* Lung Tx
* Bilateral lesions
Minimum Eligible Age

18 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

RN, MScN

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Herbert Decaluwé, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Alessia Stanzi, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Christophe Dooms, MD, PhD

Role: STUDY_CHAIR

Universitaire Ziekenhuizen KU Leuven

Paul De Leyn, MD, PhD

Role: STUDY_DIRECTOR

Universitaire Ziekenhuizen KU 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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pN+VATS

Identifier Type: -

Identifier Source: org_study_id