Clinical trial NCT01985659: 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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Lymph Node Excision
Thoracic Surgical Procedures
Thoracic Surgery, Video-Assisted
Thoracotomy
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2013-11-15
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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 criteria: 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

Primary outcomes:
measure: proportion of N upstaging
timeFrame: at time of surgical resection
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Herbert Decaluwé, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Alessia Stanzi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Christophe Dooms, MD, PhD
role: STUDY_CHAIR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Paul De Leyn, MD, PhD
role: STUDY_DIRECTOR
References: