Overview

This trial is active, not recruiting.

Condition carcinoma, non-small-cell lung
Sponsor University Hospital, Gasthuisberg
Start date November 2013
End date February 2014
Trial size 900 participants
Trial identifier NCT01985659, pN+VATS

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
In the first cohort(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.

Primary Outcomes

Measure
proportion of N upstaging
time frame: at time of surgical resection

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Cohort Analysis of Nodal Upstaging in the Era of Increase of VATS Anatomical Resections for NSCLC
Principal investigator Herbert Decaluwé, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by University Hospital, Gasthuisberg.