Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01278888 |
| Other study ID # |
s-20080085 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2008 |
| Est. completion date |
September 18, 2017 |
Study information
| Verified date |
October 2020 |
| Source |
Odense University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Is thoracoscopic surgery better than traditional open surgery for lung cancer?
Video assisted thoracoscopic surgery for lung cancer (VATS) is presumed to be less traumatic
than traditional open surgery for lung cancer but this has never been documented in a
randomized trial. Some surgeons hesitate to use VATS because it is technically more
demanding, others question if the two methods are oncologically equal. Regardless, VATS has
been implemented as a routine method for lung cancer surgery several places around the world
including Odense University Hospital. The investigators have launched the first randomized
controlled trial in the world comparing the two surgical methods to investigate any
differences in length of hospitalization, postoperative pain, life quality within the first
year, and health economics.
The investigators include patients with stage I and II lung cancer, and randomize between
VATS and open surgery in a design where both the patient and doctors doing general rounds in
the ward are blinded until discharge because the dressing on the surgical wound is identical,
regardless of the surgical method. The surgeon cannot influence clinical decisions including
time to discharge, which is decided by other specialist surgeons. Pain evaluation is
performed 6 times daily using the VAS-score, life quality is evaluated continuously during
the first 12 months using EQ5D and EORTC QLQC-30 questionnaires, and the consumption of
analgetics in both groups are monitored via the national prescription database.
Parallel to this trial a similar clinical study, which is also the first of its kind in the
world, has been launched for patients with lung cancers not eligible for VATS. They are
randomized between the two traditional open surgical methods (anterolateral and
posterolateral thoracotomy) - this is also blinded to both patient and doctors doing rounds
until discharge from hospital, and endpoint are similar in the two studies.
206 patients have been randomized in the first substudy (VATS vs. open) and 88 in the second
substudy (posterolateral vs. anterolateral).
Description:
Is minimally invasive surgery for non small cell lung cancer better than traditional open
surgery?
Surgical resection remains the best treatment for non small cell lung carcinoma (NSCLC),but
unfortunately many patients suffer major postoperative morbidity - pain being the most
frequent. It is assumed that newer minimally invasive surgical techniques (Video Assisted
Thoracoscopic Surgery - VATS) reduces postoperative morbidity but there is no level 1
evidence available in the literature. This prompted us to perform the present ongoing study,
which is the first of its kind in the world.
The investigators compare VATS with traditional open surgery for early stage lung cancer in a
clinical randomized double blinded trial. Our aims are to evaluate differences in
postoperative pain, life quality, and health economical aspects. The results of this trial
could influence future surgical decisionmaking internationally on the surgical treatment for
lung cancer.
Likewise, in patients with larger tumours of the lung, which are not suitable for minimally
invasive surgery, different techniques are available. The most widely used techniques are the
posterolateral thoracotomy and the anterolateral thoracotomy. So far no randomized controlled
trail has shown which of these techniques to be superior. This has led us to also randomize
between anterolateral and the posterolateral thoracotomy (muscle sparing). The same endpoints
are used.
Pain following lung surgery has been a much discussed topic for a long time in the field of
thoracic surgery. Depending on the reference, up to 50% of patients develop chronic pain
after open lung surgery. Therefore, different surgical approaches have been developed
including anterior, lateral or posterior thoracotomy with or without sparing the chest wall
muscles. The intercostal nerve is also of concern because of trauma from the rib retractor
which is believed to be a cause of both acute and chronic pain. Other concerns are the amount
of divided tissue, extend of rib displacement by the rib retractor, type of analgesics,
administration form of analgesics, and administration time of the analgesics and it is
generally accepted that pain in lung cancer patients is multifactorial.
VATS was introduced in an attempt to reduce the surgical trauma with less tissue damage,
avoidance of the rib retraction and the consequently intercostal nerve injury, but never the
less several patients develop chronic pain after lung surgery by VATS.
Information on quality of life and health economical aspects following surgery for lung
cancer are scarce. No randomized controlled trial has been published. Very little is known if
lung cancer patients regain their workability and if so to what extent following surgery.
Likewise, it is not known if VATS is more costly than open procedures, as the opponents say,
or if increased expenses during hospitalization are saved by earlier return to work.
End points
1. Postoperative pain evaluated using the VAS-score and the need for prescription
analgetics 2, 4, 8, 12, 26 and 52 weeks after surgery.
2. Health related life quality and workability and -efficiency in the same period, using
three different questionnaires: two concerning life quality (EORTC-QLQC-30 and EQ5D) and
one concerning workability (WPAI).
3. Health economical aspect such as application for pension, visits to general
practitioner, readmitted to hospital, number of days away from work due to postoperative
morbidity, etc.
All gathered from different databases managed by "Danmarks Statistik" here among the
"Landspatientregistret(LPR)", "Sygesikringsstatistikregistret" ,and
"Lægemiddelstatistik-registret".
206 patients admitted to the department of cardiothoracic surgery, Odense University
Hospital, for elective surgery for lung cancer will be included in each study.
Design
This research project has three sub studies: Two randomized controlled and double blinded
clinical trials, and one registry study. One clinical trial randomizes patients with small
peripheral lung cancer between VATS (Video Assisted Thoracoscopic Surgery) and standard open
anterolateral thoracotomy. The second clinical trial randomizes between anterolateral and
posterolateral open thoracotomy in patients not eligible for VATS. The registry sub study
monitors patients use of analgetics during the first 12 months
(lægemiddelstatestik-registret), their use of other health services, and return to work.
All patients will be operated in general anaesthesia with a double lumen tracheal tube and an
epidural catheter. The epidural catheter will be removed when all chest tubes has been
removed, but no later than postoperative day 4.
As a standard all patients will be given paracetamol and NSAID in standard doses, and if
needed opioids (oxycontin/oxynorm) can be added.
All surgical techniques will be performed as routine operations.
Three different surgical techniques will be used.
1. The VATS approach: one camera port and three assistance ports one of which is enlarged
to 5 cm. and rib retractors are never used.
2. Anterolateral thoracotomy: The incision is made from the posterior axillary fold
following the linea inframammary to a point below the papilla.
3. Posterolateral thoracotomy. The incision is made from the anterior axillary fold
backwards towards the inferior angle of the scapula, without dividing the dorsal
latissimus muscle.
In both clinical trials postoperative pain is evaluated by a visual analog scale (VAS). Pain
is measured during rest and during coughing. Measurements are done preoperatively and 6 times
daily during their hospital stay. After discharge measurements are recorded after 2, 4, 8,
12, 26, and 52 weeks by mail questionnaire.
Both patients and the staff doing general rounds postoperatively will be blinded. In the
operating room a dressing will be placed so that it covers the entire hemithorax whereby the
incision is hidden. This is done identically regardless of surgical technique. This dressing
is left in place until discharge. If changing of the dressing is needed, either the
project-nurse or a nurse for another team will assist.
The surgical note is kept in a sealed envelope, which is always placed in the patients chart
and can be opened in case of emergency. The chart will only include information about which
lobe was resected, no details on the surgical access, but this information is added when the
patient is discharged.
The surgeon who has performed the operation will be allowed to check up on their own
patients, and to be consulted by the other doctors doing rounds, but they are not allowed to
influence on decision-making regarding pain relief or discharge, during the postoperative
period.
Timeline
This project is a combination of a ph.d-study and a residency/fellowship in cardiothoracic
surgery because this allows for a longer inclusion period. The timeline is divided into three
research periods and three clinical periods.
This research project has already been accepted as a ph.d.-project at the University of
Southern Denmark, and approved by the local ethical board.
