Nodal Upstaging in VATS Anatomical Resections for NSCLC

November 10, 2013 updated by: Johnny Moons, University Hospital, Gasthuisberg

Cohort Analysis of Nodal Upstaging in the Era of Increase of VATS Anatomical Resections for NSCLC

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • University Hospital Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
open thoracotomy
In the first cohort(20007-2009) almost all patients where operated through a thoracotomy.
Early VATS
In a second cohort, (2010-2011) the experience with vats was early.
Standardized VATS
In the third period (2012-2013), a standardized vats technique with extensive intrapulmonary and mediastinal lymphadenectomy was used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportion of N upstaging
Time Frame: at time of surgical resection
clinical N0 to pathological N1 clinical N0 to pathological N2 clinical N1 to pathological N2
at time of surgical resection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gasthuisberg

Investigators

  • Principal Investigator: Herbert Decaluwé, MD, Universitaire Ziekenhuizen KU Leuven
  • Principal Investigator: Alessia Stanzi, MD, Universitaire Ziekenhuizen KU Leuven
  • Study Chair: Christophe Dooms, MD, PhD, Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ANTICIPATED)

February 1, 2014

Study Completion (ANTICIPATED)

June 1, 2014

Study Registration Dates

First Submitted

November 10, 2013

First Submitted That Met QC Criteria

November 10, 2013

First Posted (ESTIMATE)

November 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 15, 2013

Last Update Submitted That Met QC Criteria

November 10, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pN+VATS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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