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Spots Global Cancer Trial Database for Nodal Upstaging in VATS Anatomical Resections for NSCLC

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Trial Identification

Brief Title: Nodal Upstaging in VATS Anatomical Resections for NSCLC

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

Study ID: NCT01985659

Interventions

Study Description

Brief Summary: 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: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University Hospital Leuven, Leuven, , Belgium

Contact Details

Name: Herbert Decaluwé, MD

Affiliation: Universitaire Ziekenhuizen KU Leuven

Role: PRINCIPAL_INVESTIGATOR

Name: Alessia Stanzi, MD

Affiliation: Universitaire Ziekenhuizen KU Leuven

Role: PRINCIPAL_INVESTIGATOR

Name: Christophe Dooms, MD, PhD

Affiliation: Universitaire Ziekenhuizen KU Leuven

Role: STUDY_CHAIR

Name: Paul De Leyn, MD, PhD

Affiliation: Universitaire Ziekenhuizen KU Leuven

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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