Clinical trial · Interventional
Treatment of Early Stage Lung Cancer by VATS Versus OPEN Lobectomy
thoracoSCopic Versus OPen Lobectomy for Early Stage Lung Cancer: a Randomized Prospective Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In patients with early stage lung cancer surgical lobectomy is the treatment of choice. A resection by Video-assisted Thoracic Surgery (VATS) is probably superior to an open procedure by thoracotomy for patients with early stage lung cancer, but randomized evidence for superiority is lacking. Furthermore, VATS lobectomy has not gained broad implementation yet. The objective of this study is to assess the benefits of VATS- over open lobectomy regarding quality of life and costs in a prospective randomized controlled multicenter trial. All patients meeting the inclusion criteria that are not randomized will be included in a prospective Cohort.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OPEN lobectomy | Procedure | — | UNRESOLVED |
| ROBOT-assisted lobectomy | Device | — | UNRESOLVED |
| VATS lobectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- OPEN lobectomy
- description
- Lobectomy and mediastinal lymph node dissection by thoracotomy with rib-spreading.
- interventionNames
- Procedure: OPEN lobectomy
- type
- ACTIVE_COMPARATOR
- label
- VATS lobectomy
- description
- Thoracoscopic minimally invasive lobectomy with thoracoscopic mediastinal lymph node dissection without rib-spreading.
- interventionNames
- Procedure: VATS lobectomy
- type
- OTHER
- label
- ROBOT-assisted lobectomy
- description
- Robot-assisted lobectomy with mediastinal lymph node dissection (Robot group as clinical assignment in prospective Cohort).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Non-small cell lung carcinoma, pathologically confirmed or strong suspicion based on imaging. * T1 or T2a (≤ 5 cm) on computer tomography (CT). * Primary aim is lobectomy. * Tumor not in close relation to the hilar structures (bronchus,vessels)based on CT. * Clinically staged N0 (no regional lymph node metastasis) or N1 (metastasis to ipsilateral, hilar, interlobar- and/or intrapulmonary lymph nodes), M0 (no distant metastasis) after clinical staging according to the current Dutch guideline (may 2011). Exclusion Criteria: * T2b, T3 or T4 tumor (7th guideline TNM classification NSCLC). * Mediastinal lymph node metastasis (N2, N3). * Distant metastasis (M1). * Previous thoracic surgery on same side. * Pneumonectomy as primary aim.
References
Publications (0)
Data not yet available