To compare quality of life, cost-effectivenessand number of dissected mediastinal lymph node as a derivative oncologic outcome between open- and VATS lobectomy.
ID
Source
Brief title
Condition
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints are postoperative quality of life, number of dissected
mediastinal lymph nodes for oncologic staging, hospital length of stay and
overall costs.
Secondary outcome
Secondary endpoints include procedural complication rates, pulmonary function
and survival.
Background summary
Surgical lobectomy is the treatment of choice for patients with early stage
lung cancer. In some centres, video-assisted thoracic surgery (VATS) lobectomy
is preferred, where several other centres hold on to the conventional open
lobectomy via a thoracotomy. Although several studies have demonstrated fewer
postoperative complications and shorter hospital length of stay for the VATS
procedure, others reported concerns regarding oncologic staging. Convincing
randomized evidence from the literature is lacking. The aim of this randomized
multicentre study is to compare quality of life, oncologic endpoints and
cost-effectiveness between VATS- and open (thoracotomy) lobectomy.
Study objective
To compare quality of life, cost-effectivenessand number of dissected
mediastinal lymph node as a derivative oncologic outcome between open- and VATS
lobectomy.
Study design
A prospective multi-centre randomized trial.
Intervention
One group is assigned to the open procedure: posterolateral thoracotomy for
lobectomy with mediastinal lymph node dissection. The other group is assigned
to the VATS procedure: thoracoscopic minimally invasive lobectomy with
thoracoscopic mediastinal lymph node dissection.
Study burden and risks
Centres participating in this study currently perform the open- and VATS
lobectomy in daily clinical practice. Either intervention therefore does not
introduce an extra risk for the patient. Assessment of quality of life and
pain scores carry an extra burden for the patient, but are necessary elements
to define the difference between open- and VATS lobectomy. There is no direct
benefit for patients to participate.
Geert Grooteplein 10, postbus 9101
6500 HB Nijmegen
NL
Geert Grooteplein 10, postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Patients selected by multidisciplinary oncologic team to undergo lobectomy
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 is not in close relation to central structures (main bronchus, pulmonary artery or pulmonary veins) and is surrounded by lung parenchym (based on CT).
Clinically staged N0 or N1 (lymfnodes), 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL40542.091.12 |