Chirurgische behandeling van niet-kleincellig longcarcinoom (NSCLC):
thoracoscopisch ondersteunende minithoracotomie (VAMT) versus spiersparende thoracotomie (MST)

Cancer is the leading cause of death before the age of 85 years resulting in
more than half a million deaths per year in the United States [1]. In 2005,
primary lung cancer was the second leading cancer type in the United States
with approximately 190,000 new cases to be estimated for 2006. Among all cancer
types, lung cancer has the highest death rate [1].
Lung cancer is usually treated by surgical resection and/or cytostatic drug
administration depending on the disease stage. Stage I (a and b) and II
non-small cell lung cancer (NSCLC) are currently treated by surgical resection
and adjuvant cytostatic therapy resulting in a 5-year survival of 75, 60 and
40% respectively [2].
Anatomical lobectomy with mediastinal lymph node staging is the generally
accepted treatment for patients with stage I and II NSCLC [3]. Sublobar
resections like segmentectomy or wedge resection result in a higher local
recurrence rate probably due to micrometastatic lymphogenic disease present at
the moment of surgery [3]. In contrast, the type of resection for pulmonary
metastases does not affect survival [4].
Since 1992, an increasing number of papers report of video-assisted lobectomy
(VATS) in stead of conventional thoracotomy for the treatment of stage 1 NSCLC.
VATS is defined as *complete* if surgery is performed completely by
visualization through a television monitor. However, certain types of
operations like segmentectomy and bronchoplasty (sleeve resection) are very
difficult to perform using the *complete** technique. In contrast, **hybrid
VATS or video-assisted mini-thoracotomy (VAMT)* is a compromise between VATS
and conventional thoracotomy and combines surgical view by television
monitoring and direct vision using a muscle-sparing mini-thoracotomy [5].
Currently, less than 5% of all lobectomies are performed using the VATS
technique [6].
Short-term advantages of VAMT using a rib retractor are shown in most
retrospective studies such as decreased pain and blood loss, shorter chest tube
drainage, less immunological respons, lower complication rate, lower hospital
charges, shorter hospital admission and better pulmonary function tests
postoperatively [7,8,9,15]. Other studies, including two prospective trials
(one of them was not randomized) failed to show advantages of lobectomy by VAMT
compared to muscle-sparing thoracotomy (MST) [11,16,17].
On the other hand, operation time is often longer compared to conventional
thoracotomy [8] and conversion sometimes occur due to mediastinal lymph node
involvement, adhesion, bleeding or anomaly that are all also depending on the
experience of the surgeon [10]. But we hypothesize that in case of more
experience, the operation time could even be shorter than with a conventional
thoracotomy. Furthermore, the adequacy for complete lymph node dissection by
VAMT is controversial [11,12]. Yamashita showed a higher chance of seeding
tumour cells into the circulation during VAMT compared to open surgery [13].
However, very little is known about the adequacy on long-term survival of VAMT.
Some retrospective studies describe promising 5-year survival rates between
64-97% for stage I disease that should be interpreted carefully because of the
risk of understaging due to very strict selection criteria [14,15]. The
occurrence of entmetastases, known as a possible complication of oncological
VAMT surgery, has never been described.

At present, prospective randomized trials failed to show advantages of
lobectomy by VAMT using a rib retractor compared to MST. Therefore, this study
evaluates short- and long-term outcome of patients suffering from stage I and
IIa NSCLC prospectively randomized for lobectomy by VAMT without the use of a
rib retractor or by MST.

NB: We hereby declare that this study will performed according the approved
protocol by the ethics committee (VCMO, Sint Antonius Ziekenuis Nieuwegein),
ICH-GCP and the WMO regulations.

At present, retrospective studies suggest short-term advantages of lobectomy by
video-assisted minithoracotomy compared to muscle-sparing thoracotomy for the
treatment of non-small-cell lung cancer like less blood loss and less pain
postoperatively. However, one randomized prospective trial failed to show
advantages of VAMT lobectomy using a rib retractor while another prospective
non-randomized trial using a rib retractor showed short-term advantages. We
hypothesize that lobectomy by VAMT without rib retractor results in less pain
(page 4-6 protocol). Therefore, we propose a prospective randomized trial
evaluating short- and long-term outcome of patients suffering from stage 1 and
2a non-small cell lung cancer treated by lobectomy by VAMT without rib
retractor or by MST.

Design: prospective, randomized, open
Duration: for each patient 5 years
Expected inclusion period: 2 years (total study duration: 7 years): the
inclusion period is expected to start from 01-01-2007 tot 01-01-2009; the study
will finish 5 years later (01-01-2014)
Flow chart (see addendum):
a. Day 0
· quality of life: SF-36 (nulmeting)
· operation (lobectomy by VAMT or MST)
· at 8 hours postoperatively: VAS or mL used
b. Day 1 and 2
· 2 times/day: VAS or mL used
c. Day 3-discharge
· 3 times/day VAS
d. Days 0, 1, 2, 5 and 8
· lab: CRP and leucocytes
e. Day 7: quality of life: SF-36
f. 1 month after discharge
· consultation pulmonologist
· quality of life: SF-36
· physical examination
g. 3 months after discharge
· physical examination
· quality of life: SF-36
· pulmonary function tests
d. 3 and 5 years after discharge
· physical examination
· quality of life: SF-36

VAMT or MST

waarschijnlijk leidt de te testen techniek (VAMT) tot minder pijn, complicaties
en kortere opnameduur tov de standaard behandeling