Nodal Upstaging in VATS Anatomical Resections for NSCLC

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01985659
• Other study ID #: pN+VATS
• Status: Active, not recruiting
• Phase: N/A
• First received: November 10, 2013
• Last updated: November 10, 2013
• Start date: November 2013
• Est. completion date: June 2014

Study information

• Verified date: November 2013
• Source: University Hospital, Gasthuisberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 900
• Est. completion date: June 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Locations

Country	Name	City	State
Belgium	University Hospital Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gasthuisberg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of N upstaging	clinical N0 to pathological N1 clinical N0 to pathological N2 clinical N1 to pathological N2	at time of surgical resection	No